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Oximeter

FDA product code DQA · 702 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.2700
Review panel: AN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-04-28 – 2026-05-29

DQA 2026-05-29

Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)

Applicant Philips Medizin Systeme Böblingen GmbH

K number K252821

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DQA 2026-05-11

Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)

Applicant Shenzhen Imdk Medical Technology Co., Ltd.

K number K252655

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DQA 2026-05-01

Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)

Applicant Philips Medizin Systeme

K number K253887

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DQA 2026-04-14

Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)

Applicant Unimed Medical Supplies, Inc.

K number K260931

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DQA 2026-02-27

AViTA Pulse Oximeter (SP61)

Applicant Avita Corporation

K number K252448

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DQA 2026-02-17

YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)

Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K number K252805

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DQA 2026-01-07

Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)

Applicant Shenzhen Best Electronics Co., Ltd.

K number K253109

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DQA 2025-12-19

Spo2 Sensor CSS032D

Applicant Shenzhen Ykd Technology Co., Ltd.

K number K251751

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DQA 2025-12-01

Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)

Applicant Unimed Medical Supplies, Inc.

K number K251696

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DQA 2025-12-01

Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)

Applicant Unimed Medical Supplies, Inc.

K number K251691

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DQA 2025-11-18

Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)

Applicant Unimed Medical Supplies, Inc.

K number K251695

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DQA 2025-11-18

Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)

Applicant Unimed Medical Supplies, Inc.

K number K251693

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DQA 2025-09-25

Pulse Oximeter

Applicant Shanghai Berry Electronic Tech Co., Ltd.

K number K250837

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DQA 2025-08-13

Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)

Applicant Unimed Medical Supplies, Inc.

K number K250931

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DQA 2025-05-09

Avidhrt Sense SpO2

Applicant Avidhrt, Inc.

K number K241086

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DQA 2025-02-28

Pulse Oximeter ( PO2, PO2A, PO2B)

Applicant Shenzhen Viatom Technology Co., Ltd.

K number K242876

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DQA 2025-02-25

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)

Applicant Taiwan Aulisa Medical Devices Technologies, Inc.

K number K233963

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DQA 2025-02-20

Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)

Applicant Unimed Medical Supplies, Inc.

K number K243086

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DQA 2025-02-19

AViTA Pulse Oximeter (SP62B)

Applicant Avita Corporation

K number K242455

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DQA 2025-02-06

Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)

Applicant Unimed Medical Supplies, Inc.

K number K242580

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DQA 2025-01-30

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)

Applicant Taiwan Aulisa Medical Devices Technologies, Inc.

K number K233956

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DQA 2025-01-02

Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)

Applicant Hunan Accurate Bio-Medical Technology Co., Ltd.

K number K243049

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DQA 2024-11-29

Evie Med Ring

Applicant Movano Inc. Dba Movano Health

K number K241090

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DQA 2024-11-21

Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH

Applicant Shenzhen Smallsignal Technology Co., Ltd.

K number K232520

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DQA 2024-10-25

Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)

Applicant Shenzhen Yimi Life Technology Co., Ltd.

K number K240092

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DQA 2024-10-11

Belun Ring BLR-200 (BLR-200)

Applicant Belun Technology Company Limited

K number K234110

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DQA 2024-10-03

Pulse Oximeter (WS20A)

Applicant Hunan Accurate Bio-Medical Technology Co., Ltd.

K number K240808

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DQA 2024-08-28

OxiWear

Applicant Oxiwear, Inc.

K number K233827

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DQA 2024-08-16

Mecun SpO2 sensor

Applicant Shenzhen Mecun Medical Supply Co., Ltd.

K number K231979

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DQA 2024-07-01

Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K number K232989

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DQA 2024-06-21

Pulse Oximeter (MD300C228)

Applicant Beijing Choice Electronic Technology Co., Ltd.

K number K232975

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DQA 2024-05-28

ANNE Limb

Applicant Sibel Health, Inc.

K number K240305

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DQA 2024-05-20

AViTA Pulse Oximeter

Applicant Avita Corporation

K number K223399

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DQA 2024-05-16

Sempulse Halo Vital Signs Monitor

Applicant Sempulse Corporation

K number K232495

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DQA 2024-03-04

Vyvo

Applicant Vyvo Technology Corp.(Vt)

K number K231288

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DQA 2024-01-04

Pulse Oximeter(Model OHT60,OXH78)

Applicant Cofoe Medical Technology Co., Ltd.

K number K230277

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DQA 2023-12-21

Pediarity™

Applicant Hinlab, Inc.

K number K231531

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DQA 2023-12-15

Masimo Stork

Applicant Masimo Corporation

K number K223721

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DQA 2023-11-30

Wrist Pulse Oximeter

Applicant Beijing Choice Electronic Technology Co., Ltd.

K number K230587

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DQA 2023-10-31

Finger Clip Pulse Oximeter

Applicant Guangdong Genial Technology Co., Ltd.

K number K231243

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DQA 2023-09-07

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue

Applicant Masimo Corporation

K number K232389

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DQA 2023-08-29

circul™ pro Ring

Applicant Bodimetrics, LLC

K number K221361

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DQA 2023-08-12

Pulse Oximeter

Applicant Beijing Choice Electronic Technology Co., Ltd.

K number K230172

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DQA 2023-07-17

Pulse Oximeter

Applicant Shenzhen Brav Electronic Technologies Co., Ltd.

K number K211143

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DQA 2023-06-16

BabySat 3

Applicant Owlet Babycare, Inc.

K number K222597

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DQA 2023-05-04

Finger Pulse Oximeter, Model: X1906P

Applicant Shenzhen Changkun Technology Co., Ltd.

K number K221798

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DQA 2023-04-16

Masimo Rad-G with Temperature

Applicant Masimo Corporation

K number K213676

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DQA 2023-03-08

Pulse Oximeter

Applicant Beijing Choice Electronic Technology Co., Ltd.

K number K220101

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DQA 2023-02-26

Handheld Pulse Oximeter

Applicant Shenzhen Witleaf Medical Electronics Co., Ltd.

K number K213431

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DQA 2022-12-30

Biobeat Platform-2 and BB-613WP Patch

Applicant Biobeat Technologies , Ltd.

K number K222010

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DQA 2022-12-30

Fingertip Pulse Oximeter

Applicant Shenzhen Witleaf Medical Electronics Co., Ltd.

K number K213430

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DQA 2022-12-19

Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)

Applicant Unimed Medical Supplies, Inc.

K number K222213

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DQA 2022-12-16

Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)

Applicant Shenzhen Zhengkang Technology Co., Ltd.

K number K213984

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DQA 2022-11-20

Empatica Health Monitoring Platform

Applicant Empatica S.r.l.

K number K221282

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DQA 2022-11-18

Polso Watch

Applicant Chronisense Medical, Ltd.

K number K220351

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DQA 2022-11-08

Oxyfit Pulse Oximeter

Applicant Shenzhen Viatom Technology Co., Ltd.

K number K203812

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DQA 2022-10-16

Pulse Oximeter (Model C101A2, C101B1, C101A3)

Applicant Shenzhen Imdk Medical Technology Co., Ltd.

K number K221979

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DQA 2022-08-16

YUWELL Finger Pulse Oximeter

Applicant Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

K number K212385

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DQA 2022-08-04

Masimo CARESCAPE SpO2 – Masimo with SpHb

Applicant Masimo Corporation

K number K221953

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DQA 2022-06-22

Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)

Applicant Huizhou Xiaoou Technology Co., Ltd.

K number K212665

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DQA 2022-06-12

Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System

Applicant Taiwan Aulisa Medical Devices Technologies, Inc.

K number K203208

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DQA 2022-06-10

WesperO2

Applicant Wesper, Inc.

K number K213515

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DQA 2022-05-20

Med-link Pulse Oximeter

Applicant Shenzhen Med-Link Electronics Tech Co., Ltd.

K number K212752

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DQA 2022-05-06

Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC

Applicant Covidien, LLC

K number K212555

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DQA 2022-03-25

Biobeat Platform, BB-613WP Patch

Applicant Biobeat Technologies , Ltd.

K number K212153

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DQA 2022-03-08

Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2

Applicant Stryker Sustainability Solutions

K number K211140

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DQA 2022-02-25

Pulse Oximeter

Applicant Shenzhen Mericonn Technology Co., Ltd.

K number K212300

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DQA 2022-02-11

Pulse Oximeter

Applicant Beijing Choice Electronic Technology Co., Ltd.

K number K211400

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DQA 2022-01-14

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

Applicant Shenzhen Narig Bio-Medical Technology Co., Ltd.

K number K211632

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DQA 2021-12-22

Pulse Oximeter

Applicant Dongguan Lingxin Technologies Co., Ltd.

K number K210305

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DQA 2021-10-21

Belun Ring BLR-100X

Applicant Belun Technology Company Limited

K number K211407

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DQA 2021-10-08

Carescape SpO2 - Masimo

Applicant Masimo Corporation

K number K212876

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DQA 2021-09-01

Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)

Applicant Leadtek Research, Inc.

K number K210032

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DQA 2021-07-30

Fingertip Pulse Oximeter

Applicant Zhuhai Linte Medical Instrument Co., Ltd.

K number K210274

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DQA 2021-07-23

VS Newborn Heart Rate Monitor

Applicant Surepulse Medical Limited

K number K201887

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DQA 2021-04-23

Pulse Oximeter

Applicant Shenzhen Hexin Zondan Medical Equipment Co., Ltd.

K number K203854

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DQA 2021-03-01

Fingertip pulse oximeter

Applicant Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.

K number K202776

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DQA 2021-03-01

Med-Link Temp-pulse Oximeter

Applicant Shenzhen Med-Link Electronics Tech Co., Ltd.

K number K202743

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DQA 2021-01-25

Pulse Oximeter

Applicant Shenzhen Creative Industry Co., Ltd.

K number K201468

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DQA 2020-12-14

Fingertip Pulse Oximeter

Applicant Shenzhen Bsx Technology Electronics Co., Ltd.

K number K202324

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DQA 2020-12-07

Pulse Oximeter

Applicant Shenzhen AOJ Medical Technology Co., Ltd.

K number K202173

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DQA 2020-12-07

Pulse Oximeter

Applicant Shenzhen Raysintone Technology Co., Ltd.

K number K201384

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DQA 2020-11-27

Spo2 Sensor

Applicant Jkh USA, LLC

K number K202851

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DQA 2020-11-27

Pulse Oximeter

Applicant Guangdong Long Yao Electronic Technology Co., Ltd.

K number K201294

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DQA 2020-09-24

Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor

Applicant Masimo Corporation

K number K201770

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DQA 2020-09-23

Pulse Oximeter

Applicant Shenzhen Aeon Technology Co., Ltd.

K number K200414

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DQA 2020-08-19

Reusable and Disposable SpO2 Sensors

Applicant Xinkang Medical Instrument Co. , Ltd.

K number K201360

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DQA 2020-07-20

GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable

Applicant Covidien, LLC

K number K201179

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DQA 2020-07-03

Oxxiom

Applicant True Wearables, Inc.

K number K200537

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DQA 2020-06-29

H500 Multi-Sensing Oximetry System

Applicant Nonin Medical, Inc.

K number K192900

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DQA 2020-04-27

Leadtek Fingertip Pulse Oximeter

Applicant Leadtek Research, Inc.

K number K193350

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DQA 2020-04-09

OxSAT 100

Applicant S.L.P. , Ltd.

K number K191574

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DQA 2020-03-13

Disposable SpO2 Sensor

Applicant Shenzhen Changke Connect Electronics Co., Ltd.

K number K200069

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DQA 2020-01-24

Disposable SpO2 Sensor

Applicant Shenzhen Sino-K Medical Technology Co.,Ltd

K number K192608

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DQA 2019-12-31

Patient Monitor

Applicant Shenzhen Creative Industry Co., Ltd.

K number K192343

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DQA 2019-12-20

Pulse Oximeter

Applicant Nonin Medical, Inc.

K number K191403

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DQA 2019-12-06

Disposable SpO2 Sensor

Applicant Shenzhen Caremed Medical Technology Co., Ltd.

K number K191279

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DQA 2019-12-02

Checkme O2 Pulse Oximeter

Applicant Shenzhen Viatom Technology Co., Ltd.

K number K191088

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DQA 2019-10-18

Pulse Oximeter

Applicant Shenzhen Yimi Life-Technology Co., Ltd.

K number K191430

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DQA 2019-10-11

Reusable SpO2 Sensor

Applicant Shenzhen Changke Connect Electronics Co., Ltd.

K number K191420

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