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 1998-06-08

NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES

Applicant Nihon Kohden America, Inc.

K number K974292

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DQA 1998-04-30

E100 SERIES SPO2 SENSORS

Applicant Epic Medical Equipment Services, Inc.

K number K970098

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DQA 1998-04-24

APEX OXIMETER

Applicant Marquette Medical Systems, Inc.

K number K980299

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DQA 1998-03-25

BCI 3401 HANDHELD PULSE OXIMETER

Applicant Bci Intl., Inc.

K number K980714

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DQA 1998-01-16

METRON QA-510 SPO2 ANALYZER

Applicant Metron U.S., Inc.

K number K973991

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DQA 1998-01-08

MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES

Applicant Masimo Corp.

K number K973887

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DQA 1997-11-14

NPB-295 PULSE OXIMETER

Applicant Nellcor Puritan Bennett, Inc.

K number K973147

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DQA 1997-10-28

CRICKET 2000 RECORDING PULSE OXIMETER

Applicant Respironics, Inc.

K number K972829

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DQA 1997-10-21

NPB-290 PULSE OXIMETER (NPB-290)

Applicant Nellcor Puritan Bennett, Inc.

K number K972837

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DQA 1997-10-17

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366

Applicant Alexander Mfg. Co.

K number K972786

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DQA 1997-10-10

SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)

Applicant Somanetics Corp.

K number K971628

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DQA 1997-10-08

INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF

Applicant Bio-Tek Instruments, Inc.

K number K971273

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DQA 1997-09-25

NPB-195 PULSE OXIMETER

Applicant Nellcor Puritan Bennett, Inc.

K number K972468

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DQA 1997-09-25

ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)

Applicant Datascope Corp.

K number K970061

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DQA 1997-09-04

SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER

Applicant Siemens Medical Solutions USA, Inc.

K number K973222

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DQA 1997-08-28

COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR

Applicant Aristo Medical

K number K970769

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DQA 1997-08-25

NPB-190 PULSE OXIMETER (NPB-190)

Applicant Nellcor Puritan Bennett, Inc.

K number K971946

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DQA 1997-08-12

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115

Applicant Alexander Mfg. Co.

K number K971828

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DQA 1997-08-12

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764

Applicant Alexander Mfg. Co.

K number K971827

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DQA 1997-07-16

OXIMETER PRE-AMP CABLE

Applicant Epic Medical Equipment Services, Inc.

K number K965172

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DQA 1997-07-16

COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67

Applicant Ventrex, Inc.

K number K964821

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DQA 1997-07-14

MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR

Applicant Medical Data Electronics

K number K970763

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DQA 1997-06-05

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W

Applicant Alexander Mfg. Co.

K number K971235

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DQA 1997-05-21

VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)

Applicant Quinton, Inc.

K number K964978

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DQA 1997-05-06

SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER

Applicant Siemens Medical Solutions USA, Inc.

K number K970368

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DQA 1997-02-21

FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)

Applicant Epic Medical Equipment Services, Inc.

K number K964055

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DQA 1997-02-11

8500A PULSE OXIMETER

Applicant Nonin Medical, Inc.

K number K945290

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DQA 1997-02-06

MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES

Applicant Masimo Corp.

K number K962603

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DQA 1996-12-13

NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)

Applicant Nellcor Puritan Bennett, Inc.

K number K963707

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DQA 1996-12-04

SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE

Applicant Emg Scientific

K number K952315

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DQA 1996-11-26

OXI TEMP

Applicant Bci Intl., Inc.

K number K963496

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DQA 1996-10-10

OHMEDA 3800 PULSE OXIMETER

Applicant Ohmeda Medical

K number K962127

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DQA 1996-09-12

E100A PULSE OXIMETER FINGER SENSOR/PROBE

Applicant Epic Medical Equipment Services, Inc.

K number K954168

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DQA 1996-08-28

3304 PULSE OXIMETER

Applicant Bci Intl., Inc.

K number K962156

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DQA 1996-08-01

SCORE SOFTWARE

Applicant Nellcor Puritan Bennett, Inc.

K number K961450

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DQA 1996-06-05

SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)

Applicant Somanetics Corp.

K number K960614

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DQA 1996-05-15

OXITEMP, 3301T SA

Applicant Bci Intl., Inc.

K number K960058

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DQA 1996-05-03

BURDICK 200 PULSE OXIMETER

Applicant Burdick, Inc.

K number K954267

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DQA 1996-03-26

COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR

Applicant Aristo Medical Products, Inc.

K number K960251

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DQA 1995-11-29

9267 SPO2 ATHENA MODULE

Applicant S & W Medico Teknik

K number K940933

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DQA 1995-11-22

ARISTO MEDICAL MODEL 2101 PATIENT MONITOR

Applicant Aristo Medical Products, Inc.

K number K953817

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DQA 1995-09-21

OXILINK (SMALL, MEDIUM, LARGE)

Applicant Bci Intl., Inc.

K number K953126

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DQA 1995-08-25

SMARTSAT PULSE OXIMETRY ANALYZER

Applicant Clinical Dynamics Corp.

K number K952327

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DQA 1995-08-17

NELLCOR SYMPHONY N-3000 PULSE OXIMETER

Applicant Nellcor, Inc.

K number K952316

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DQA 1995-08-15

NELLCOR N-20PA PORTABLE PULSE OXIMETER

Applicant Nellcor, Inc.

K number K952222

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DQA 1995-07-17

NEWOX2

Applicant Bci Intl., Inc.

K number K945754

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DQA 1995-05-12

NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000

Applicant Nellcor, Inc.

K number K942347

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DQA 1995-03-24

PULSE OXIMETER MODEL 305

Applicant Palco Laboratories, Inc.

K number K943842

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DQA 1995-03-17

3301T OXITEMP

Applicant Bci Intl., Inc.

K number K946185

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DQA 1995-02-16

HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE

Applicant Hewlett-Packard GmbH

K number K942842

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DQA 1995-02-01

FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE

Applicant Fukuda Denshi USA, Inc.

K number K945464

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DQA 1994-12-08

MINIATURIZED FINGER CLIP PULSE OXIMETER

Applicant Nonin Medical, Inc.

K number K942248

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DQA 1994-10-18

MARQUETTE ADULT/NEONATAL WRAP SENSOR

Applicant Marquette Electronics, Inc.

K number K943817

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DQA 1994-10-17

AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT

Applicant Datex Division Instrumentarium Corp.

K number K943456

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DQA 1994-10-13

3301 PULSE OXIMETER

Applicant Bci Intl., Inc.

K number K943404

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DQA 1994-10-13

BURDICK PRO2 OXIMETER

Applicant Burdick Corp.

K number K941351

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DQA 1994-10-04

HP M1722A/B AND M1723A/B CODEMASTER

Applicant Hewlett-Packard Co.

K number K944608

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DQA 1994-09-29

OHMEDA HAND HELD OXIMETER

Applicant Ohmeda Medical

K number K931304

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DQA 1994-09-01

INDEX SPO2 SIMULATOR

Applicant Bio-Tek Instruments, Inc.

K number K933519

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DQA 1994-08-16

SENSOR SHIELD, MODIFICATION

Applicant Medical Taping Systems, Inc.

K number K933755

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DQA 1994-07-19

VITALMAX 530

Applicant Pace Tech Medical Monitors, Inc.

K number K932203

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DQA 1994-07-01

VX4 RECORDING PULSE OXIMETER

Applicant Vitalog Monitoring,Inc.

K number K935510

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DQA 1994-06-22

PULSE OXIMETER

Applicant Bci Intl., Inc.

K number K941289

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DQA 1994-04-11

BIOCHEM MODEL 3302 NEWOX2 OXIMETER

Applicant Biochem International, Inc.

K number K920083

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DQA 1994-04-01

FUKUDA DENSHI MODEL HG-301

Applicant Fukuda Denshi USA, Inc.

K number K921454

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DQA 1994-03-15

OXISAT

Applicant Marquette Electronics, Inc.

K number K934091

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DQA 1994-03-14

NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS

Applicant Nonin Medical, Inc.

K number K940463

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DQA 1993-12-03

NOVAMETRIX MODEL 510

Applicant Novametrix Medical Systems, Inc.

K number K924626

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DQA 1993-09-10

FREEDOM OXIMETER/EEG DIGITAL INTERFACE

Applicant Pro-Tech, Inc.

K number K924752

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DQA 1993-07-16

SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT)

Applicant Aristo Medical Products, Inc.

K number K920966

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DQA 1993-05-27

NELLCOR PORTABLE PULSE OXIMETER MODEL N-20

Applicant Nellcor, Inc.

K number K915699

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DQA 1993-05-11

MODEL 3500 MR-COMPATIBLE PULSE OXIMETER

Applicant Magnetic Resonance Equipment Corp.

K number K924285

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DQA 1993-05-07

MODEL 320 MR-COMPATIBLE PULSE OXIMETER

Applicant Magnetic Resonance Equipment Corp.

K number K924282

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DQA 1993-03-16

PALCO LABS MODEL 340 PULSE OXIMETER

Applicant Palco Laboratories, Inc.

K number K920066

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DQA 1993-02-23

9293/1 INTERFACE MODULE

Applicant S & W Medico Teknik

K number K923418

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DQA 1993-02-17

OXYSHUTTLE II ,MODIFICATION

Applicant Sensor Medics Corp.

K number K925542

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DQA 1993-02-10

HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER

Applicant Hewlett-Packard Co.

K number K923343

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DQA 1993-01-07

BIOCHEM MODEL 3301 NEWOX1 OXIMETER

Applicant Biochem International, Inc.

K number K920082

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DQA 1992-12-23

SENSOR SHIELD

Applicant Medical Taping Systems, Inc.

K number K910811

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DQA 1992-11-04

AVOXIMETER

Applicant A-Vox Systems, Inc.

K number K922075

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DQA 1992-10-23

OXICOM-2100

Applicant Waters Instruments, Inc.

K number K921519

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DQA 1992-09-28

MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE

Applicant Hewlett-Packard Co.

K number K923682

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DQA 1992-07-15

NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX

Applicant Novametrix Medical Systems, Inc.

K number K920379

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DQA 1992-07-14

UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER

Applicant Innovative Medical Products, Inc.

K number K914538

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DQA 1992-06-24

P-300 CAPNOGRAPH AND PULSE OXIMETER

Applicant Pryon Corp.

K number K915773

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DQA 1992-06-02

CRIT-SCAN

Applicant Noninvasive Medical Technology Corp.

K number K910077

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DQA 1992-05-01

HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION

Applicant Vitalog Monitoring,Inc.

K number K914620

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DQA 1992-02-26

SENSORMEDICS OXYSHUTTLE II(TM)

Applicant Sensor Medics Corp.

K number K913790

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DQA 1991-11-14

VITALMAX 510/520

Applicant Pace Tech, Inc.

K number K912880

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DQA 1991-11-13

NELLCOR(R) N-180 PULSE OXIMETER

Applicant Nellcor, Inc.

K number K913695

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DQA 1991-11-04

MODEL 520A NOVAMETRIX PULSE OXIMETER

Applicant Novametrix Medical Systems, Inc.

K number K913516

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DQA 1991-10-31

SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION

Applicant S & W Medico Teknik

K number K911761

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DQA 1991-10-30

SIEMENS MICRO2 PULSE OXIMETER

Applicant Siemens Medical Electronics

K number K913489

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DQA 1991-10-23

CIBA CORNING MODEL 270 CO-OXIMETER

Applicant Ciba Corning Diagnostics Corp.

K number K913332

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DQA 1991-08-26

OXICOMPLUS

Applicant Waters Instruments, Inc.

K number K911207

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DQA 1991-07-18

MODEL 8604-FO PULSE OXIMETER

Applicant Nonin Medical, Inc.

K number K910001

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DQA 1991-06-10

PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR

Applicant Palco Laboratories, Inc.

K number K911191

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DQA 1991-06-07

503 PULSE OXIMETER

Applicant Criticare Systems, Inc.

K number K911124

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DQA 1991-05-28

MINIOX V PULSE OXIMETER

Applicant Catalyst Research Corp.

K number K905310

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DQA 1991-05-28

SATLITE PLUS PULSE OXIMETER

Applicant Datex Division Instrumentarium Corp.

K number K905140

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