Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 2010-12-15

V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201

Applicant Taidoc Technology Corporation

K number K101012

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DQA 2010-12-02

MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K101577

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DQA 2010-11-24

VITAL SIGNS MONITOR MODEL M3B

Applicant Edan Instruments, Inc.

K number K101539

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DQA 2010-11-18

MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1

Applicant Masimo Corporation

K number K101031

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DQA 2010-10-21

MASIMO LNCS/M-LNCS OXIMETRY SENSORS

Applicant Masimo Corporation

K number K101896

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DQA 2010-10-21

CHARMCARE TABLETOP PULSE OXIMETER

Applicant Charmcare Co., Ltd.

K number K092641

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DQA 2010-10-07

NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103

Applicant Solaris Medical Technology, Inc.

K number K100077

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DQA 2010-10-04

TRUSIGNAL SPO2 FINGERTIP SENSOR

Applicant GE Healthcare Finland Oy

K number K101871

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DQA 2010-09-20

MODEL SB100II FINGER PULSE OXIMETER

Applicant Atlantean

K number K101568

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DQA 2010-09-10

E.S.O. (ELECTRO SENSOR OXI)

Applicant Ld Technology, LLC

K number K102442

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DQA 2010-09-08

HANDHELD PULSE OXIMETER MODEL M800

Applicant Guangdong Biolight Meditech Co., Ltd.

K number K101694

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DQA 2010-08-31

INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL

Applicant Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

K number K101600

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DQA 2010-07-09

MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER

Applicant Masimo Corporation

K number K100428

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DQA 2010-06-23

MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7

Applicant Masimo Corporation

K number K100403

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DQA 2010-06-16

OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316

Applicant Oxypulse

K number K100815

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DQA 2010-06-04

SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES

Applicant Nonin Medical, Inc.

K number K093853

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DQA 2010-05-28

MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D

Applicant Masimo Corporation

K number K100617

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DQA 2010-05-17

HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K100203

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DQA 2010-05-14

LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS

Applicant Masimo Corporation

K number K094046

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DQA 2010-03-30

VITAL SIGNS MONITOR

Applicant Shenzhen Creative Industry Co., Ltd.

K number K093016

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DQA 2010-03-19

NBM-200MP PULSE OXIMETRY DEVICE

Applicant Orsense, Ltd.

K number K091564

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DQA 2010-03-12

TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR

Applicant GE Healthcare Finland Oy

K number K093881

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DQA 2010-03-12

SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES

Applicant Solaris Medical Technology, Inc.

K number K092950

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DQA 2010-03-08

DX SERIES FINGER SENSOR

Applicant Dixtal Medical, Inc.

K number K100020

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DQA 2010-03-04

SINGLE-PATIENT USE DISPOSABLE SENSOR

Applicant Nonin Medical, Inc.

K number K093306

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DQA 2010-03-03

MD300C1 FINGERTIP PULSE OXIMETER

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K093757

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DQA 2010-01-08

FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K092652

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DQA 2009-12-04

MD300C318 FINGERTIP PULSE OXIMETER

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K092620

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DQA 2009-12-03

H100B PULSE OXIMETER

Applicant Edan Instruments, Inc.

K number K092727

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DQA 2009-11-16

OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P

Applicant Bio Medical Technologies Co., Ltd.

K number K092549

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DQA 2009-11-06

MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER

Applicant Masimo Corporation

K number K091241

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DQA 2009-10-21

REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES

Applicant Nonin Medical, Inc.

K number K092101

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DQA 2009-10-15

MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8

Applicant Masimo Corporation

K number K092838

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DQA 2009-10-09

MODEL 6000 TWO PARAMETER BEDSIDE MONITOR

Applicant Ivy Biomedical Systems, Inc.

K number K091787

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DQA 2009-10-01

EVISION DATA MANAGEMENT SOFTWARE

Applicant Nonin Medical, Inc.

K number K092678

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DQA 2009-09-22

DISPOSABLE SPO2 SENSOR M1134A

Applicant Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

K number K091572

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DQA 2009-09-03

SPIROPRO

Applicant Viasys Healthcare GmbH

K number K092324

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DQA 2009-08-20

CABLE, TRANSDUCER, MODEL 2400GN

Applicant Conmed Corporation

K number K083448

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DQA 2009-08-10

MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP

Applicant Masimo Corporation

K number K090662

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DQA 2009-07-24

REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR

Applicant Envitec-Wismar GmbH

K number K090438

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DQA 2009-07-20

MD300K1 PULSE OXIMETER

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K090599

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DQA 2009-07-09

MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES

Applicant Masimo Corporation

K number K091057

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DQA 2009-07-09

RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20

Applicant Masimo Corporation

K number K090165

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DQA 2009-06-11

PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D

Applicant Contec Medical System Co., Ltd.

K number K090671

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DQA 2009-06-10

SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR

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

K number K083010

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DQA 2009-05-14

VITAL SIGNS MONITOR

Applicant Edan Instruments, Inc.

K number K083821

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DQA 2009-05-04

PHILIPS M3001A MULTI MEASUREMENT SERVER

Applicant Philips Medizin Systeme Boblingen GmbH

K number K090360

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DQA 2009-05-01

BCI WW1030 PULSE OXIMETER

Applicant Smiths Medical Pm, Inc.

K number K083557

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DQA 2009-04-28

BCI WW1021 PC APPLICATION

Applicant Smiths Medical Pm, Inc.

K number K090205

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DQA 2009-04-24

PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P

Applicant Comdek Industrial Corp.

K number K083351

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DQA 2009-04-15

BCI WW1000 PULSE OXIMETER, MODEL WW1000

Applicant Smiths Medical Pm, Inc.

K number K083787

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DQA 2009-04-09

BCI WW1020 PULSE OXIMETER, MODEL WW1020

Applicant Smiths Medical Pm, Inc.

K number K083705

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DQA 2009-04-03

MD2000A VITAL SIGN MONITOR, MODEL MD2000A

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K083466

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DQA 2009-04-03

APK SPO2 PULSE OXIMETER SENSOR

Applicant APK Technology Co., Ltd.

K number K082846

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DQA 2009-04-02

LNCS OXIMETRY SENSORS

Applicant Masimo Corporation

K number K083622

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DQA 2009-03-19

FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)

Applicant Cas Medical Systems, Inc.

K number K083892

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DQA 2009-03-09

N-600X WITH SPD, OXIMAX N-600X

Applicant Covidien

K number K083325

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DQA 2009-03-05

QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100

Applicant Quanta Computer, Inc.

K number K083079

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DQA 2009-03-04

M-50 SERIES SPO2 SENSOR

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K082487

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DQA 2009-02-06

CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX

Applicant Oridion Capnography, Inc.

K number K082268

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DQA 2009-01-15

MIROXI

Applicant Mir Medical Intl. Research Srl

K number K081033

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DQA 2009-01-07

G1B PULSE OXIMETER

Applicant General Meditech, Inc.

K number K082789

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DQA 2008-12-02

REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91)

Applicant Unimed Medical Supplies, Inc.

K number K082546

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DQA 2008-11-26

INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997

Applicant Draeger Medical Systems, Inc.

K number K082888

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DQA 2008-11-10

FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL

Applicant Contec Medical System Co., Ltd.

K number K082641

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DQA 2008-10-10

MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK

Applicant Masimo Corporation

K number K082052

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DQA 2008-10-09

OXISCAN II DATA MANAGEMENT SYSTEM

Applicant Airsep Corp.

K number K080348

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DQA 2008-10-01

SMARTSIGNS MINPULSE

Applicant Huntleigh Healthcare , Ltd.

K number K081572

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DQA 2008-09-24

T12S TELEMETRY TRANSMITTER

Applicant Mortara Instrument, Inc.

K number K081800

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DQA 2008-09-12

FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700

Applicant Guangdong Biolight Meditech Co., Ltd.

K number K081712

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DQA 2008-09-09

RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L

Applicant Masimo Corporation

K number K081659

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DQA 2008-08-29

PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE

Applicant Philips Medizin Systeme Boeblingen GmbH

K number K081937

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DQA 2008-07-31

MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO

Applicant GE Healthcare Finland Oy

K number K081870

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DQA 2008-07-25

SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES

Applicant Solaris Medical Technology, Inc.

K number K073249

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DQA 2008-07-02

WRIST PULSE OXIMETER MD300W

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K081125

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DQA 2008-06-05

FINGER PULSE OXIMETER, MODEL 9560

Applicant Nonin Medical, Inc.

K number K081285

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DQA 2008-05-23

NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER

Applicant Nonin Medical, Inc.

K number K080255

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DQA 2008-05-12

MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER

Applicant Masimo Corporation

K number K080238

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DQA 2008-05-05

FINGERTIP PULSE OXIMETER, MODEL CMS-50C

Applicant Contec Medical System Co., Ltd.

K number K073454

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DQA 2008-05-02

MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER

Applicant Mediaid, Inc.

K number K071642

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DQA 2008-02-25

FORE-SIGHT, MC-2000 SERIES

Applicant Cas Medical Systems, Inc.

K number K073036

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DQA 2008-02-08

MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES

Applicant Masimo Corporation

K number K073024

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DQA 2008-01-14

FINGERTIP PULSE OXIMETER, MODEL MD300I

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K072825

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DQA 2008-01-08

PM-60 PULSE OXIMETER

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K072581

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DQA 2007-11-05

MEDIAID PULSE OXIMETER M30 AND M34

Applicant Mediaid, Inc.

K number K071610

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DQA 2007-10-19

PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K072235

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DQA 2007-10-11

CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE

Applicant Oridion Capnography, Inc.

K number K072295

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DQA 2007-09-12

SENTEC DIGITAL MONITORING SYSTEM

Applicant Sentec AG

K number K071672

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DQA 2007-08-13

FINGERTIP PULSE OXIMETER MD300C

Applicant Beijing Choice Electronic Technololgy Co., Ltd.

K number K070371

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DQA 2007-08-08

DIGITAL PULSE OXIMETER, MODEL 7500FO

Applicant Nonin Medical, Inc.

K number K071415

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DQA 2007-07-13

PC-60, NON-INVASIVEPULSE OXIMETER

Applicant Shenzhen Creative Industry Co., Ltd.

K number K063641

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DQA 2007-07-12

DIGITAL PULSE OXIMETER, MODEL 7500

Applicant Nonin Medical, Inc.

K number K071285

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DQA 2007-07-09

BCI AUTOCON 3304 DIGITAL PULSE OXIMETER

Applicant Smiths Medical Pm, Inc.

K number K070732

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DQA 2007-06-29

MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS

Applicant Masimo Corporation

K number K071024

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DQA 2007-05-31

SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES

Applicant International Business Strategies

K number K062149

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DQA 2007-05-25

DURAMAX REUSABLE OXIMETRY SENSOR

Applicant Nellcor Puritan Bennett, Inc.

K number K070408

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DQA 2007-05-11

ACCUPULSE PULSE OXIMETER

Applicant Eagle Medical Equipment Co.

K number K062724

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DQA 2007-05-04

LIFESENSE, MODEL LS1-9R

Applicant Nonin Medical, Inc.

K number K063752

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DQA 2007-05-02

ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES

Applicant Envitec-Wismar GmbH

K number K070193

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DQA 2007-04-27

PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A

Applicant Philips Medical Systems, Inc.

K number K063783

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