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 2007-04-12

MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N

Applicant Mediaid, Inc.

K number K061896

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DQA 2007-03-05

CADWELL EASYNET OXIMETER MODULE

Applicant Cadwell Laboratories, Inc.

K number K061706

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DQA 2007-01-31

SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101

Applicant Solaris Medical Technology, Inc.

K number K061931

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DQA 2007-01-22

TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

Applicant Radiometer Basel AG

K number K063434

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DQA 2006-12-29

RAINBOW ADHESIVE CO-OXIMETRY SENSORS

Applicant Masimo Corporation

K number K063140

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DQA 2006-11-15

TENACORE SP02 SENSORS

Applicant Tenacore Holdings, Inc.

K number K053420

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DQA 2006-11-09

PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T

Applicant Philips Medical Systems

K number K062605

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DQA 2006-11-03

PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL

Applicant Philips Medical Systems

K number K062455

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DQA 2006-10-25

TELEVISIT

Applicant PHD Medical

K number K062338

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DQA 2006-10-18

MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03

Applicant Philips Medical Systems North America Co.

K number K062268

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DQA 2006-09-29

PULSE OXIMETER ADAPTER CABLES

Applicant American I.V. Products, Inc.

K number K052544

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DQA 2006-09-05

PULSE OXIMETER, MODEL PM-50

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

K number K061442

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DQA 2006-08-14

NELLCOR OXIMAX N-600X PULSE OXIMETER

Applicant Nellcor Puritan Bennett, Inc.

K number K060576

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DQA 2006-07-27

MASIMO SET RADICAL 7 PULSE CO-OXIMETER

Applicant Masimo Corporation

K number K061204

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DQA 2006-07-17

ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS

Applicant Envitec-Wismar GmbH

K number K060675

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DQA 2006-07-07

INFINITY MASIMO SET SP02 POD

Applicant Draeger Medical Systems, Inc.

K number K061329

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DQA 2006-06-29

NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100

Applicant PHD Medical

K number K060616

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DQA 2006-06-16

LNCS AND SPO2.COM SENSORS

Applicant Masimo Corporation

K number K060143

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DQA 2006-06-15

DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES

Applicant Dolphin Medical, Inc.

K number K060524

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DQA 2006-06-15

WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE

Applicant Welch Allyn, Inc.

K number K053381

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DQA 2006-05-22

FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2

Applicant Measurement Specialties, Inc.

K number K061191

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DQA 2006-05-22

CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M

Applicant Conmed Corporation

K number K061112

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DQA 2006-05-11

KONICA MINOLTA PULSOX-300, 300I

Applicant Konica Minolta Sensing, Inc.

K number K053419

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DQA 2006-05-04

CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR

Applicant Oridion Capnography, Inc.

K number K060065

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DQA 2006-04-20

MODIFICATION TO HEALTH BUDDY APPLIANCE

Applicant Health Hero Network, Inc.

K number K060843

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DQA 2006-03-30

PM-50 PULSE OXIMETER

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

K number K052693

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DQA 2006-03-16

MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS

Applicant Masimo Corporation

K number K053477

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DQA 2006-01-11

ONYX II FINGER PULSE OXIMETER, MODEL 9550

Applicant Nonin Medical, Inc.

K number K053130

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DQA 2006-01-10

OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR

Applicant Nellcor Puritan Bennett, Inc.

K number K051271

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DQA 2006-01-06

THE FINGER GUARD

Applicant T F & G Products

K number K052619

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DQA 2005-12-23

AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100

Applicant Nonin Medical, Inc.

K number K052669

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DQA 2005-12-22

ADULT CEREBRAL OXIMETER, MODEL 2040

Applicant Cas Medical Systems, Inc.

K number K051257

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DQA 2005-12-21

MASIMO SET RAD-8 PULSE OXIMETER

Applicant Masimo Corporation

K number K053269

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DQA 2005-12-02

FOX PULSE OXIMETER

Applicant Shunsuke Nakanishi

K number K051736

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DQA 2005-11-17

PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.

Applicant Philips Medizin Systeme Boeblingen GmbH

K number K052377

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DQA 2005-11-10

WRISTOX MODEL 3100 PULSE OXIMETER

Applicant Nonin Medical, Inc.

K number K052829

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DQA 2005-11-10

NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P

Applicant Nellcor Puritan Bennett, Inc.

K number K052186

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DQA 2005-10-13

DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT

Applicant GE Healthcare

K number K052755

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DQA 2005-08-11

OXIMAX NPB-40 HANDHELD PULSE OXIMETER

Applicant Nellcor Puritan Bennett, Inc.

K number K051352

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DQA 2005-07-15

LNOP BLUE OXIMETRY SENSOR

Applicant Masimo Corporation

K number K051439

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DQA 2005-07-12

MODIFICATION TO LNCS OXIMETRY SENSORS

Applicant Masimo Corporation

K number K051212

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DQA 2005-07-01

TESLAOXYSAT, MODEL EFOXYSATE

Applicant Mammendorfer Institute For Physics & Medicine GmbH

K number K050018

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DQA 2005-06-23

750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL

Applicant Cas Medical Systems, Inc.

K number K050844

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DQA 2005-06-21

MODEL 2500A PALMSAT PULSE OXIMETER

Applicant Nonin Medical, Inc.

K number K050056

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DQA 2005-06-01

ONYX II FINGER PULSE OXIMETER, MODEL 9550

Applicant Nonin Medical, Inc.

K number K051107

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DQA 2005-05-11

AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS

Applicant Masimo Corporation

K number K050252

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DQA 2005-02-11

ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS

Applicant Envitec-Wismar GmbH

K number K043463

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DQA 2005-02-09

LNOPV AD-L AND PD-L OXIMETRY SENSORS

Applicant Masimo Corporation

K number K050068

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DQA 2005-01-19

MASIMO SET RAD 57 PULSE CO-OXIMETER

Applicant Masimo Corporation

K number K042536

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DQA 2005-01-07

4100 PATIENT OXIMETER MODULE

Applicant Nonin Medical, Inc.

K number K043359

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DQA 2004-12-29

PMP4 OXY PRO

Applicant Card Guard Scientific Survival , Ltd.

K number K043162

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DQA 2004-12-29

DISPOSABLE NON-ADHESIVE SPO2 SENSORS

Applicant Elekon Industries U.S.A., Inc.

K number K042705

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DQA 2004-11-26

REUSABLE FINGER CLIP SPO2 SENSORS

Applicant Elekon Industries U.S.A., Inc.

K number K042704

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DQA 2004-10-15

PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A

Applicant Philips Medizin Systeme Boeblingen GmbH

K number K042306

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DQA 2004-10-12

ETG-4000 OPTICAL TOPOGRAPHY SYSTEM

Applicant Hitachi Medical Corp.

K number K042501

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DQA 2004-09-20

LNCS OXIMETRY SENSORS

Applicant Masimo Corporation

K number K042346

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DQA 2004-09-14

MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS

Applicant Mediaid, Inc.

K number K041964

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DQA 2004-09-14

FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS

Applicant Elekon Industries U.S.A., Inc.

K number K041522

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DQA 2004-09-10

PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE

Applicant S.P.O. Medical Equipment, Ltd.

K number K040178

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DQA 2004-09-02

FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)

Applicant Elekon Industries U.S.A., Inc.

K number K041647

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DQA 2004-08-31

DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420

Applicant Dolphin Medical, Inc.

K number K040380

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DQA 2004-08-31

PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200

Applicant Conmed Corporation

K number K032831

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DQA 2004-08-26

TIDAL WAVE SP MODEL 710/715 AND 715

Applicant Respironics Novametrix, Inc.

K number K032971

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DQA 2004-08-23

SPOT CHECK PULSE OXIMETER,512/513

Applicant Respironics Novametrix, Inc.

K number K032949

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DQA 2004-07-29

LNCS OXIMETRY SENSORS

Applicant Masimo Corp.

K number K041815

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DQA 2004-07-29

FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

Applicant Elekon Industries U.S.A., Inc.

K number K041644

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DQA 2004-07-19

THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT

Applicant Philips Medical Systems

K number K041674

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DQA 2004-06-29

NC SP02 ADAPTER CABLE

Applicant Masimo Corp.

K number K041204

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DQA 2004-06-09

AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001

Applicant Nonin Medical, Inc.

K number K041156

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DQA 2004-06-03

MODIFICATION TO AVANT 9600 PULSE OXIMETER

Applicant Nonin Medical, Inc.

K number K040589

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DQA 2004-05-27

MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM

Applicant Vitel Net

K number K040581

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DQA 2004-05-21

MODEL 509M PULSE OXIMETER, MODEL 509M

Applicant Respironics Novametrix, Inc.

K number K032755

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DQA 2004-05-06

NVISION DATA MANAGEMENT SOFTWARE

Applicant Nonin Medical, Inc.

K number K033307

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DQA 2004-04-22

MASIMO SET INTELLIVUE PULSE OXIMETER MODULE

Applicant Masimo Corp.

K number K040259

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DQA 2004-03-19

MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V

Applicant Masimo Corp.

K number K033998

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DQA 2004-03-11

DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422

Applicant Dolphin Medical, Inc.

K number K033876

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DQA 2004-02-25

MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

Applicant Masimo Corp.

K number K040214

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DQA 2004-02-20

PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T

Applicant Philips Medical Systems, Inc.

K number K032979

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DQA 2004-02-19

MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V

Applicant Masimo Corp.

K number K033296

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DQA 2004-02-19

MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR

Applicant Masimo Corp.

K number K032551

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DQA 2004-02-13

PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER

Applicant Philips Medical Systems, Inc.

K number K033715

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DQA 2004-01-28

AC-1 SP02 ADAPTOR CABLE, MODEL AC-1

Applicant Masimo Corp.

K number K033349

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DQA 2003-12-12

SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS

Applicant Masimo Corp.

K number K033298

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DQA 2003-11-25

DRAEGER MICRO2+ AND MASIMO MINISAT

Applicant Draeger Medical Systems, Inc.

K number K032537

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DQA 2003-11-14

SPIROPRO SPO2

Applicant Viasys Healthcare GmbH

K number K031515

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DQA 2003-10-17

NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210

Applicant Dolphin Medical, Inc.

K number K032947

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DQA 2003-10-17

MODEL 3100 WRISTOX PULSE OXIMETER

Applicant Nonin Medical, Inc.

K number K030668

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DQA 2003-10-10

MODEL 2100 PULSE OXIMETER

Applicant Dolphin Medical, Inc.

K number K031465

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DQA 2003-09-04

DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER

Applicant Dolphin Medical, Inc.

K number K030629

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DQA 2003-08-26

VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES

Applicant Welch Allyn Protocol, Inc.

K number K031740

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DQA 2003-08-18

BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER

Applicant Bci, Inc.

K number K031742

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DQA 2003-07-23

PICOSAT II SPO2 PULSE OXIMETRY MODULE

Applicant Philips Medical Systems

K number K030973

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DQA 2003-07-23

MODEL 9600, AVANT PULSE OXIMETER

Applicant Nonin Medical, Inc.

K number K023044

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DQA 2003-06-03

SIEMENS MICRO2+ WITH VAI SOFTWARE

Applicant Siemens Medical Solutions USA, Inc.

K number K030640

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DQA 2003-05-23

OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N

Applicant Nellcor Puritan Bennett, Inc.

K number K030930

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DQA 2003-05-19

DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421

Applicant Dolphin Medical, Inc.

K number K030952

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DQA 2003-05-12

MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

Applicant Masimo Corp.

K number K031330

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DQA 2003-04-03

MICROCAP PLUS/NPB-75

Applicant Oridion Medical 1987 , Ltd.

K number K024300

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DQA 2003-03-17

DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER

Applicant Dolphin Medical, Inc.

K number K024235

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DQA 2003-03-07

IM2001 PULSE OXIMETER

Applicant Imagyn Medical Technologies, Inc.

K number K012706

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