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 2003-02-12

MINOLTA PULSOX-2

Applicant Konica Minolta Sensing, Inc.

K number K021469

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DQA 2002-11-15

VITALSAT SERIES

Applicant Beta Biomed Services, Inc.

K number K011518

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DQA 2002-11-07

OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'

Applicant Dolphin Medical, Inc.

K number K014218

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DQA 2002-10-08

TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES

Applicant Datex-Ohmeda, Inc.

K number K021955

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DQA 2002-09-26

ATLAS MONITOR, MODELS 200,210,220

Applicant Welch Allyn, Inc.

K number K022084

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DQA 2002-09-24

NELLCOR N-200 PULSE OXIMETER, MODEL N-200

Applicant Nellcor Puritan Bennett, Inc.

K number K022819

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DQA 2002-09-17

WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506

Applicant Welch Allyn, Inc.

K number K022163

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DQA 2002-09-11

MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE

Applicant Alaris Medical Systems, Inc.

K number K022677

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DQA 2002-09-05

SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER

Applicant Siemens Medical Solutions USA, Inc.

K number K022766

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DQA 2002-08-01

DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N

Applicant Ge Medical Systems Information Technologies

K number K022193

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DQA 2002-08-01

ENVOY

Applicant Mennen Medical , Ltd.

K number K022168

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DQA 2002-07-23

INFINITY MICRO2+

Applicant Siemens Medical Solutions USA, Inc.

K number K012770

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DQA 2002-07-17

PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B

Applicant Philips Medical Systems

K number K021778

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DQA 2002-07-11

DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100

Applicant Dolphin Medical, Inc.

K number K021959

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DQA 2002-06-19

OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR

Applicant Nellcor Puritan Bennett, Inc.

K number K021089

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DQA 2002-06-03

BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR

Applicant Bci, Inc.

K number K020739

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DQA 2002-05-13

SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3

Applicant Sensidyne, Inc.

K number K021246

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DQA 2002-05-08

OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER

Applicant Nellcor Puritan Bennett, Inc.

K number K021090

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DQA 2002-04-30

BCI 3180 PULSE OXIMETER

Applicant Bci, Inc.

K number K020350

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DQA 2002-04-09

HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER

Applicant Hommed, LLC

K number K014025

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DQA 2002-03-26

DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES

Applicant Datex-Ohmeda

K number K020479

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DQA 2002-03-20

DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070

Applicant Dolphin Medical, Inc.

K number K012989

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DQA 2002-03-07

OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)

Applicant Nellcor Puritan Bennett, Inc.

K number K012891

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DQA 2002-02-21

BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM

Applicant Bci, Inc.

K number K013862

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DQA 2002-02-12

SENSAID

Applicant Sensidyne, Inc.

K number K011974

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DQA 2002-02-08

MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER

Applicant Dolphin Medical, Inc.

K number K020075

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DQA 2002-01-25

MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414

Applicant Medical Data Electronics

K number K014294

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DQA 2002-01-03

NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR

Applicant Nonin Medical, Inc.

K number K013319

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DQA 2002-01-03

3420 DIGIT PULSE OXIMETER, MODEL 3420

Applicant Bci, Inc.

K number K013171

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DQA 2001-12-20

FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE

Applicant Fukuda Denshi USA, Inc.

K number K013273

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DQA 2001-12-11

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

Applicant Masimo Corp.

K number K013792

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DQA 2001-11-02

OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR

Applicant Osi Medical, Inc.

K number K012626

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DQA 2001-10-26

VITALSAT PULSE OXIMETER, MODEL IC32000

Applicant Island Critical Care Corp.

K number K011365

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DQA 2001-10-03

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

Applicant Masimo Corp.

K number K012992

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DQA 2001-08-22

MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES

Applicant Osi Medical, Inc.

K number K012533

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DQA 2001-08-09

ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM

Applicant Hitachi Medical Systems America, Inc.

K number K011320

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DQA 2001-08-02

MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI

Applicant Konica Minolta Sensing, Inc.

K number K010413

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DQA 2001-07-11

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

Applicant Masimo Corp.

K number K011851

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DQA 2001-06-26

DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE

Applicant Datex-Ohmeda

K number K011670

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DQA 2001-06-14

BCI 3403 SLEEP SCREENING PULSE OXIMETER

Applicant Bci, Inc.

K number K011156

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DQA 2001-06-08

MEDLEY SP02 MODULE, MODEL 8220

Applicant Alaris Medical Systems, Inc.

K number K010966

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DQA 2001-05-24

SPO2 WRAP SENSOR

Applicant Epic Medical Equipment Services, Inc.

K number K002848

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DQA 2001-04-25

NOVAMETRIX MARQUETTE COMPATIBLE SENSORS

Applicant Novametrix Medical Systems, Inc.

K number K010451

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DQA 2001-04-17

OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD

Applicant Osi Medical, Inc.

K number K002036

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DQA 2001-04-06

PREAMP CABLE, MODEL B400-1011PA

Applicant Beta Biomed Services, Inc.

K number K003542

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DQA 2001-03-29

FINGER PULSE METER

Applicant Bhs Intl., Inc.

K number K000814

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DQA 2001-03-15

DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES

Applicant Datex-Ohmeda, Inc.

K number K010463

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DQA 2001-03-06

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

Applicant Masimo Corp.

K number K010419

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DQA 2001-03-02

HOMMED SENTRY III PATIENT MONITOR SYSTEM

Applicant Hommed, LLC

K number K004044

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DQA 2001-03-01

PROFOX SOFTWARE, MODEL 920M-41

Applicant Respironics Georgia, Inc.

K number K001708

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DQA 2000-11-29

MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120

Applicant Palco Labs, Inc.

K number K002787

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DQA 2000-11-08

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

Applicant Masimo Corp.

K number K003244

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DQA 2000-11-08

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

Applicant Masimo Corp.

K number K003167

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DQA 2000-10-18

SOLAR SPO2 MODULE WITH MASIMO SET

Applicant General Electric Medical Systems Information Techn

K number K002957

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DQA 2000-10-11

MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500

Applicant Nonin Medical, Inc.

K number K002690

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DQA 2000-10-06

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

Applicant Masimo Corp.

K number K002939

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DQA 2000-10-05

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

Applicant Masimo Corp.

K number K002751

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DQA 2000-09-15

ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100

Applicant Somanetics Corp.

K number K001842

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DQA 2000-09-13

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

Applicant Masimo Corp.

K number K002682

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DQA 2000-09-08

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

Applicant Masimo Corp.

K number K002477

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DQA 2000-09-08

SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER

Applicant Qrs Diagnostic, LLC

K number K001995

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DQA 2000-09-06

MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT

Applicant Masimo Corp.

K number K002574

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DQA 2000-08-30

MINOLTA PULSOX-3/MINOLTA PULSOX-3I

Applicant In-X Corp.

K number K984570

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DQA 2000-08-22

EPIC SPO2 FINGER SENSOR, MODEL E412-20

Applicant Epic Medical Equipment Services, Inc.

K number K002223

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DQA 2000-07-20

MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500

Applicant Nonin Medical, Inc.

K number K001930

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DQA 2000-07-05

BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A

Applicant Bci, Inc.

K number K001770

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DQA 2000-06-30

DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER

Applicant Datex-Ohmeda, Inc.

K number K001688

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DQA 2000-06-05

STAT-SHELL DISPOSABLE SP02 SENSOR

Applicant Epic Medical Equipment Services, Inc.

K number K000831

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DQA 2000-05-17

MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW

Applicant Agilent Technologies

K number K001308

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DQA 2000-05-01

MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500

Applicant Nonin Medical, Inc.

K number K001085

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DQA 2000-04-28

MODEL 120

Applicant Palco Labs, Inc.

K number K994372

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DQA 2000-04-14

MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA

Applicant Masimo Corp.

K number K000126

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DQA 2000-04-10

MODIFICATION TO MARSPO2, MODEL 2001

Applicant Novametrix Medical Systems, Inc.

K number K000794

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DQA 2000-03-31

DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER

Applicant Datex-Ohmeda, Inc.

K number K993512

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DQA 2000-03-29

MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED

Applicant Envitec-Wismar GmbH

K number K992215

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DQA 2000-02-22

MARSPO2, MODEL 2001

Applicant Novametrix Medical Systems, Inc.

K number K993979

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DQA 2000-01-07

NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES

Applicant Nihon Kohden America, Inc.

K number K992455

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DQA 1999-12-22

SPO2 WRAP SENSOR

Applicant Epic Medical Equipment Services, Inc.

K number K992211

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DQA 1999-12-22

STAT-SHELL DISPOSABLE SPO2 SENSOR

Applicant Epic Medical Equipment Services, Inc.

K number K992092

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DQA 1999-12-03

SPACELABS MEDICAL DISPOSABLE SP02 SENSOR

Applicant Spacelabs Medical, Inc.

K number K981655

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DQA 1999-11-24

N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS

Applicant Nellcor Puritan Bennett, Inc.

K number K993637

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DQA 1999-11-19

MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES

Applicant Masimo Corp.

K number K993555

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DQA 1999-10-08

MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE

Applicant Masimo Corp.

K number K992340

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DQA 1999-10-08

MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12)

Applicant Masimo Corp.

K number K992238

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DQA 1999-08-25

N-395 PULSE OXIMETER, MODEL N-395

Applicant Nellcor Puritan Bennett, Inc.

K number K991823

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DQA 1999-08-19

MAGNATEK 30

Applicant Magna Advanced Technologies, Inc.

K number K991819

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DQA 1999-06-09

3402 HANDHELD PULSE OXIMETER

Applicant Bci Intl., Inc.

K number K991410

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DQA 1999-06-07

MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS

Applicant Masimo Corp.

K number K990966

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DQA 1999-05-28

SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER

Applicant Siemens Medical Solutions USA, Inc.

K number K991661

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DQA 1999-04-09

EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09

Applicant Epic Medical Equipment Services, Inc.

K number K990082

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DQA 1998-12-07

NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C

Applicant Nellcor Puritan Bennett, Inc.

K number K982728

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DQA 1998-11-06

DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS

Applicant Datex-Ohmeda, Inc.

K number K983684

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DQA 1998-11-02

9303 NEONATAL/ADULT VITAL SIGNS MONITOR

Applicant Cas Medical Systems, Inc.

K number K982776

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DQA 1998-10-22

MODEL 2000 PULSE OXIMETER

Applicant Ivy Biomedical Systems, Inc.

K number K982255

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DQA 1998-10-06

SPO2 FINGER PROBES

Applicant Medical Cables, Inc.

K number K973970

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DQA 1998-10-02

MAGNATEK 40

Applicant Magna Advanced Technologies, Inc.

K number K982907

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DQA 1998-09-17

MTEK-1000

Applicant Magna Advanced Technologies, Inc.

K number K982405

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DQA 1998-09-11

KELLER PULSE OXIMETER, MODEL 850+

Applicant Keller Medical Specialties Products, Inc.

K number K982331

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DQA 1998-08-20

AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR

Applicant Bci Intl., Inc.

K number K981939

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DQA 1998-07-16

OSCILLOMATE NIBP / SP02 EMS MONITOR

Applicant Cas Medical Systems, Inc.

K number K980879

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