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 1991-05-14

504US PULSE OXIMETER

Applicant Criticare Systems, Inc.

K number K910770

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DQA 1991-05-14

AP-860PA NIBP MODULE

Applicant Nihon Kohden America, Inc.

K number K910629

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DQA 1991-04-18

SYSTEM 7300 PULSE OXIMETER

Applicant Advanced Medical Instruments, Inc.

K number K910521

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DQA 1991-03-18

PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR

Applicant Palco Laboratories, Inc.

K number K904988

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DQA 1991-02-05

ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC

Applicant Sentinel

K number K904088

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DQA 1990-12-27

REFLECTANCE SENSOR (RS-10)

Applicant Nellcor, Inc.

K number K904039

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DQA 1990-11-29

COROMETRICS MODEL 556 NEONATAL MONITOR

Applicant Ge Medical Systems Information Technologies

K number K900001

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DQA 1990-10-23

HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE

Applicant Hewlett-Packard Co.

K number K903523

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DQA 1990-10-22

SPO2 OPTION

Applicant Protocol Systems, Inc.

K number K902730

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DQA 1990-10-19

MODEL 90421 FLEXPORT INTERFACE

Applicant Spacelabs, Inc.

K number K903702

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DQA 1990-09-27

MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA

Applicant S & W Medico Teknik

K number K902779

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DQA 1990-08-28

VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA.

Applicant Pace Tech, Inc.

K number K901066

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DQA 1990-08-23

COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC

Applicant Cobe Laboratories, Inc.

K number K902758

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DQA 1990-08-23

MODEL MSC SA02-5000 PULSE OXIMETER

Applicant Medical Systems Corp.

K number K902192

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DQA 1990-08-23

MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP.

Applicant Ivy Biomedical Systems, Inc.

K number K901504

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DQA 1990-08-14

ITC ANGIOGRAPHIC CATHETER

Applicant Interventional Therapeutics Corp.

K number K900757

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DQA 1990-08-14

TYPE 9293 INTERFACE PULSEOX

Applicant S & W Medico Teknik

K number K896738

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DQA 1990-07-18

MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)

Applicant Hewlett-Packard Co.

K number K901819

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DQA 1990-06-19

PULSE OXIMETRY MODULE

Applicant Marquette Electronics, Inc.

K number K901071

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DQA 1990-06-12

POWERBASE II (PB2)

Applicant Nellcor, Inc.

K number K901399

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DQA 1990-06-11

ESCORT MODEL 300

Applicant Medical Data Electronics

K number K902060

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DQA 1990-05-22

HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL

Applicant Mennen Medical, Inc.

K number K901774

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DQA 1990-05-18

CAV SAT OXIMETER MODEL 100

Applicant Somanetics Corp.

K number K892217

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DQA 1990-05-15

EDENTEC MODEL 2000W SYSTEM 700 MONITOR

Applicant Edentec Corp.

K number K901060

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DQA 1990-05-09

OXYTRAK(TM) PULSE OXIMETER

Applicant Critikon Company, LLC

K number K894100

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DQA 1990-04-30

VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PRE

Applicant Pace Tech, Inc.

K number K901612

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DQA 1990-04-30

MODEL 90489 PULSE OXIMETER MODULE

Applicant Spacelabs, Inc.

K number K901209

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DQA 1990-04-04

OXIMAX 700

Applicant Pace Tech, Inc.

K number K900866

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DQA 1990-03-28

OXIMAX 100

Applicant Pace Tech, Inc.

K number K900843

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DQA 1990-02-28

MODEL 8500 HAND HELD PULSE OXIMETER

Applicant Nonin Medical, Inc.

K number K893221

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DQA 1990-02-22

KELLER PULSE OXIMETER - KMS 850

Applicant Keller Medical Specialties Products, Inc.

K number K895987

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DQA 1989-10-26

NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER

Applicant Novametrix Medical Systems, Inc.

K number K893643

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DQA 1989-09-26

MINIMON 7137B PATIENT MONITOR

Applicant Kontron Instruments, Inc.

K number K895425

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DQA 1989-09-26

ESCORT PULSE OXIMETRY OPTION

Applicant Medical Data Electronics

K number K892120

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DQA 1989-09-13

CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE

Applicant Spacelabs, Inc.

K number K893867

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DQA 1989-09-05

OXIMETER

Applicant Radiometer America, Inc.

K number K893587

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DQA 1989-08-03

SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE

Applicant Siemens Medical Electronics

K number K893470

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DQA 1989-04-25

TYPE 9266 SAO2 SYSTEM ATHENA

Applicant S & W Medico Teknik

K number K884121

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DQA 1989-03-22

SATLITE TRANS PORTABLE PULSE OXIMETER

Applicant Datex Division Instrumentarium Corp.

K number K890753

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DQA 1989-03-02

KONTRON PULSE OXIMETER 7840

Applicant Kontron Instruments, Inc.

K number K890299

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DQA 1989-03-02

MODEL OX-1 OXYGEN SATURATION MODULE

Applicant Colin Medical Instruments Corp.

K number K884822

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DQA 1989-02-23

CNS-8200A CENTRAL NURSES STATION

Applicant Nihon Kohden America, Inc.

K number K884050

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DQA 1989-02-06

MODEL 8700 PULSE OXIMETER

Applicant Nonin Medical, Inc.

K number K890033

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DQA 1989-02-06

AL-800PA PULSE OXIMETER MODULE

Applicant Nihon Kohden America, Inc.

K number K884536

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DQA 1989-02-01

EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.

Applicant Edentec Corp.

K number K884614

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DQA 1988-12-28

OC-100 OXIMETER INTERFACE CALIBRATOR

Applicant Telediagnostic Systems, Inc.

K number K884891

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DQA 1988-12-16

SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER

Applicant Baxter Healthcare Corp

K number K884329

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DQA 1988-11-04

OLV 1100; OLV 1200 PULSE OXIMETERS

Applicant Nihon Kohden America, Inc.

K number K881307

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DQA 1988-10-28

BM-103 BATTERY MODULE

Applicant Datex Division Instrumentarium Corp.

K number K883877

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DQA 1988-10-19

KONTRON PULSE OXIMETER 7840

Applicant Kontron Instruments, Inc.

K number K873624

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DQA 1988-10-06

HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER

Applicant Hewlett-Packard Co.

K number K883297

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DQA 1988-09-27

MODEL PM-20A PHYSIOLOGICAL MONITOR

Applicant Advanced Medical Systems, Inc.

K number K880756

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DQA 1988-09-16

MRL OXIMETER

Applicant Medical Research Laboratories, Inc.

K number K882664

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DQA 1988-08-25

HORIZON 2000 PULSE OXIMETRY AND MODULE

Applicant Mennen Medical, Inc.

K number K882273

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DQA 1988-07-18

SATLITE+/PB251+ PULSE OXIMETER

Applicant Datex Division Instrumentarium Corp.

K number K881883

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DQA 1988-07-18

EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER

Applicant Edentec Corp.

K number K881820

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DQA 1988-05-18

HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.

Applicant Hewlett-Packard Co.

K number K881136

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DQA 1988-05-06

SENTINEL PULSE OXIMETER

Applicant Sentinel Monitoring Technologies, Ltd.

K number K880672

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DQA 1988-04-19

SS-1000 POLYGRAPH

Applicant Meramed Corp.

K number K872520

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DQA 1988-03-22

LAWRENCE L4000 REFLECTANCE PULSE OXIMETER

Applicant Lawrence Medical Systems, Inc.

K number K874492

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DQA 1988-03-22

VITALOG HMS-3000

Applicant Vitalog Corp.

K number K874198

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DQA 1988-03-07

502-US PULSE OXIMETER

Applicant Criticare Systems, Inc.

K number K875298

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DQA 1988-03-07

SIMED S-100 PULSE OXIMETER

Applicant Simed

K number K873896

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DQA 1988-02-18

DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER

Applicant Critikon Company, LLC

K number K874442

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DQA 1988-02-12

OXYGEN/PULSE MONITOR

Applicant Healthdyne, Inc.

K number K875031

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DQA 1988-02-12

MODEL 8800 CARDIORESPIRATORY OXIMETER

Applicant Nonin Medical, Inc.

K number K874947

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DQA 1988-02-02

PULSEMATE BX-5

Applicant Colin Medical Instruments Corp.

K number K874692

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DQA 1988-02-02

OHMEDA 4700 OXICAP MONITOR

Applicant Ohmeda Medical

K number K873199

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DQA 1988-01-19

MINIOX IV PORTABLE PULSE OXIMETER

Applicant Catalyst Research Corp.

K number K874132

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DQA 1987-12-29

CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104

Applicant Datex Division Instrumentarium Corp.

K number K873859

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DQA 1987-12-03

OHMEDA BIOX 3760 PULSE OXIMETER

Applicant Ohmeda Medical

K number K874104

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DQA 1987-11-17

EDENTEC MULTI-CHANNEL RECORDER

Applicant Edentec Corp.

K number K873081

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DQA 1987-10-26

MODEL 7200A WITH PULSE OXIMETRY

Applicant Puritan Bennett Corp.

K number K873065

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DQA 1987-10-07

OHMEDA BIOX 3740 PULSE OXIMETER

Applicant Ohmeda Medical

K number K872772

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DQA 1987-10-07

PULSE-OX

Applicant Life Design Systems, Inc.

K number K863857

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DQA 1987-09-23

NOVAMETRIX MODEL 505 PULSE OXIMETER

Applicant Novametrix Medical Systems, Inc.

K number K873078

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DQA 1987-09-15

OXIMETRY MODULE

Applicant Marquette Electronics, Inc.

K number K872626

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DQA 1987-06-29

PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE

Applicant Datex Division Instrumentarium Corp.

K number K871826

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DQA 1987-06-24

PB240 PATIENT MONITOR/PULSE OXIMETER

Applicant Puritan Bennett Corp.

K number K871864

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DQA 1987-06-08

OXIMETER

Applicant Radiometer America, Inc.

K number K871353

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DQA 1987-05-06

INVIVO PULSE OXIMETER, MODEL 4500

Applicant Invivo Research Labs, Inc.

K number K864730

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DQA 1987-03-20

SATLITE/PB251 PULSE OXIMETER

Applicant Datex Division Instrumentarium Corp.

K number K870621

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DQA 1987-03-11

SPACELABS MODEL 90419 PULSE OXIMETER MODULE

Applicant Spacelabs, Inc.

K number K864279

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DQA 1987-03-04

502 OXYGEN SATURATION MONITOR

Applicant Criticare Systems, Inc.

K number K864613

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DQA 1987-03-03

BIOCHEM MICROSPAN 1040 OXIMETER

Applicant Biochem International, Inc.

K number K870163

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DQA 1987-01-07

MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT.

Applicant Marquest Medical Products, Inc.

K number K863918

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DQA 1987-01-06

ACCUSAT

Applicant Datascope Corp.

K number K863855

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DQA 1986-12-22

NELLCOR MVP, MODEL N-1000

Applicant Nellcor, Inc.

K number K862812

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DQA 1986-11-21

NELLCOR N-200 (PULSE OXIMETER)

Applicant Nellcor, Inc.

K number K863784

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DQA 1986-11-07

BIOCHEM CO/OX 1000

Applicant Biochem International, Inc.

K number K863186

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DQA 1986-09-26

SENSORMEDICS OXYSHUTTLE(TM)

Applicant Sensor Medics Corp.

K number K862617

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DQA 1986-08-28

MINIOX 100 PULSE OXIMETER

Applicant Catalyst Research Corp.

K number K862798

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DQA 1986-08-18

OSC-80 OXIMETER

Applicant Waters Instruments, Inc.

K number K862161

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DQA 1986-06-05

MODEL 8604 OXYGEN/PULSE MONITOR

Applicant Nonin Medical, Inc.

K number K860051

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DQA 1986-05-16

PULSE OXIMETER

Applicant Physio-Control Corp.

K number K855027

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DQA 1984-12-27

NELLCOR PULSE OXIMETER N-10

Applicant Nellcor, Inc.

K number K844256

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DQA 1984-05-09

MINOLTA SM-32 OXYGEN SATURATION MONIT

Applicant Marquest Medical Products, Inc.

K number K833973

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DQA 1983-12-30

BTI BIOX III OXIMETER CRITICAL CAREUNI

Applicant Biox Technology, Inc.

K number K833826

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DQA 1982-11-01

PULSE OXIMETER MODEL 100

Applicant Nellcor, Inc.

K number K822909

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DQA 1982-02-12

BIOX III

Applicant Biox Technology, Inc.

K number K820110

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