Analyzer, Gas, Oxygen, Gaseous-Phase

FDA product code CCL · 122 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.1720
Review panel: AN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-11 – 2026-07-30

CCL 2026-07-30

PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)

Applicant Salter Labs

K number K261389

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CCL 2025-08-11

OxyMinder Pro (10310)

Applicant Bio-Med Device, Inc.

K number K251245

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CCL 2025-04-24

Smart Check O2 (MA0236)

Applicant Life Spark Medical, LLC

K number K250002

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CCL 2023-04-01

Maxtec MaxO2 ME+p

Applicant Maxtec, LLC

K number K221734

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CCL 2022-08-19

Percent Oxygen Sensors

Applicant Careox, LLC

K number K213933

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CCL 2022-03-17

OxyMinder

Applicant Bio-Med Devices, Inc.

K number K213948

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CCL 2018-05-02

Accu O2 Oxygen Analyzer

Applicant Precision Medical, Inc.

K number K173807

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CCL 2016-06-10

MaxO2ME

Applicant Maxtec, LLC

K number K153659

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CCL 2013-02-28

CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES

Applicant GE Healthcare Finland Oy

K number K123195

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CCL 2013-01-23

ENVITEC MYSIGN O OXYGEN MEASURING DEVICE

Applicant Envitec-Wismar GmbH

K number K122290

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CCL 2011-12-14

ULTRAMAXO2 OXYGEN ANALYER

Applicant Maxtec, LLC

K number K112402

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CCL 2008-11-25

ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106

Applicant Envitec-Wismar GmbH

K number K082655

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CCL 2008-01-03

DIGIFLO CONCENTRATOR ANALYZER

Applicant Digiflo, Inc.

K number K072469

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CCL 2007-02-27

PRECISION OXYGEN MONITOR

Applicant Precision Medical, Inc.

K number K063096

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CCL 2007-02-22

MAXO2 CU

Applicant Maxtec, Inc.

K number K063488

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CCL 2006-04-05

OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M

Applicant Analytical Industries, Inc.

K number K053407

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CCL 2005-05-25

DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC

Applicant GE Healthcare

K number K051092

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CCL 2004-07-15

OXYGEN MEDICELS, CITICELS

Applicant City Technology Limited

K number K041773

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CCL 2004-06-09

MAXO2+, MODEL A AND AE

Applicant Maxtec, Inc.

K number K040484

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CCL 2003-07-17

RX300 OXYGEN ANALYZER

Applicant Teledyne Analytical Instruments

K number K024228

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CCL 2003-07-17

MX 300 OXYGEN MONITOR

Applicant Teledyne Analytical Instruments

K number K024155

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CCL 2003-03-28

OXICHECK

Applicant Caradyne, Ltd.

K number K023565

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CCL 2001-07-23

PRIMA OXYGEN MONITOR

Applicant Penlon , Ltd.

K number K010318

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CCL 2001-03-14

'ALL 2000' % OXYGEN ANALYZER

Applicant Analytical Industries, Inc.

K number K002382

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CCL 2001-03-01

100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I

Applicant Sensidyne, Inc.

K number K010382

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CCL 2000-12-15

M-XX OXYGEN SENSORS

Applicant International Business Strategies

K number K002384

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CCL 2000-08-31

SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR

Applicant Sensidyne, Inc.

K number K000700

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CCL 2000-06-30

OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130

Applicant Teledyne Analytical Instruments

K number K001095

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CCL 2000-02-03

TED 200T7 OXYGEN MONITOR

Applicant Teledyne Electronic Technologies

K number K990403

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CCL 1999-11-09

TED 60T OXYGEN ANALYZER

Applicant Teledyne Electronic Technologies

K number K990457

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CCL 1999-11-03

SIEMENS FIO2 SENSOR

Applicant Siemens Medical Solutions USA, Inc.

K number K991884

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CCL 1999-07-09

INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)

Applicant Invacare Corp.

K number K984295

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CCL 1999-03-17

PRO2 CHECK OXYGEN INDICATOR

Applicant Medical Technology Specialists, Inc.

K number K983500

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CCL 1998-08-12

HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02

Applicant Hewlett-Packard Co.

K number K982619

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CCL 1998-07-21

MODEL 02 OXYGEN ANALYZER

Applicant Oxigraf, Inc.

K number K971084

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CCL 1998-05-26

VACU*MED GOLD EDITION OXYGEN GAS ANALYZER

Applicant Vacumed, Div. of Vacumetrics, Inc.

K number K973545

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CCL 1998-03-30

CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS

Applicant Ceramatec, Inc.

K number K972992

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CCL 1998-03-04

HANDI OXYGEN ANALYZER

Applicant Ceramatec, Inc.

K number K973282

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CCL 1997-11-13

TED 191

Applicant Teledyne Brown Engineering

K number K963177

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CCL 1996-11-25

VENTREX OXYGEN SENSOR

Applicant Ventrex, LLC

K number K963415

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CCL 1996-11-01

GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION

Applicant Ametek, Inc.

K number K943824

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CCL 1996-07-25

MINIOX 3000 OXYGEN MONITOR

Applicant Minesafety Appliances Co.

K number K961644

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CCL 1996-01-11

OXYCHECK OXYGEN MONITOR

Applicant Oxycheck, Inc.

K number K951038

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CCL 1995-10-18

PERCENT OXYGEN SENSOR

Applicant Analytical Industries, Inc.

K number K952736

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CCL 1995-10-16

SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS

Applicant Seatronics Co.

K number K953351

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CCL 1995-06-21

OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)

Applicant Mountain Medical Equipment, Inc.

K number K941793

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CCL 1995-05-10

FI02 SENSING MODULE

Applicant Core-M, L.P.

K number K944120

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CCL 1995-05-03

OXYCHEK OXYGEN ANALYZER

Applicant Nidek Medical Products, Inc.

K number K942593

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CCL 1994-11-08

OXYGEN CONCENTRATION INDICATOR

Applicant Aequitron Medical, Inc.

K number K944654

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CCL 1994-06-14

MINIOX 1000 OXYGEN CONCENTRATION INDICATOR

Applicant Minesafety Appliances Co.

K number K935364

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CCL 1993-03-05

PRO2 OXYGEN ANALYZER

Applicant Martech Medical Products, Inc.

K number K922438

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CCL 1993-01-27

VTI OXYGEN ANALYZER

Applicant Vascular Technology Incorporated

K number K922738

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CCL 1992-08-27

COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR

Applicant Puritan Bennett Corp.

K number K920338

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CCL 1992-07-17

OXYGEN SENSING DEVICE, MODIFICATION

Applicant Devilbiss Health Care, Inc.

K number K913392

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CCL 1991-08-22

BIOCHEM TEMPERATURE/ FIO2 MODULE

Applicant Biochem International, Inc.

K number K910381

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CCL 1991-06-18

CERION HAND HELD OXYGEN ANALYZER

Applicant Ceramatec, Inc.

K number K911344

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CCL 1990-03-09

AG-820PA FI02 MODULE

Applicant Nihon Kohden America, Inc.

K number K896359

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CCL 1990-01-24

SPACELABS' MODEL 90514, MULTIGAS ANALYZER

Applicant Spacelabs, Inc.

K number K896427

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CCL 1989-11-21

VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM

Applicant Vascular Technology Incorporated

K number K890058

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CCL 1989-10-31

HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.

Applicant Mennen Medical, Inc.

K number K894918

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CCL 1989-08-31

NEONATAL ENVIRONMENTAL MONITOR, MODEL 275

Applicant Preemicare Corp.

K number K891674

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CCL 1989-05-25

OXITRON OXYGEN SENSOR

Applicant Oxitron Medical Products

K number K890144

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CCL 1989-05-22

OXITRON OXYGEN ANALYZER

Applicant Oxitron Medical Products

K number K890958

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CCL 1988-11-02

MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT.

Applicant Clinical Information Systems, Inc.

K number K882352

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CCL 1988-09-30

LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001

Applicant Lifecare Services, Inc.

K number K880378

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CCL 1988-09-12

MULTINEX MONITOR (MODIFICATION)

Applicant Datascope Corp.

K number K883254

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CCL 1988-08-24

OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)

Applicant Ohmeda Medical

K number K882743

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CCL 1988-08-19

OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES

Applicant Salter Labs

K number K881663

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CCL 1988-06-16

SL01 OXYGEN ANALYZER

Applicant Salter Labs

K number K881473

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CCL 1988-06-16

SL02 OXYGEN ANALYZER

Applicant Salter Labs

K number K881472

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CCL 1988-03-29

LC OXYGEN ANALYZER

Applicant Ametek/Thermox Instruments Division

K number K875183

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CCL 1988-03-21

CERION OXY THRESHOLD ALARM

Applicant Ceramatec, Inc.

K number K880448

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CCL 1987-10-20

OXYGEN ANALYZER MODEL 800 SERIES

Applicant Salter Instrumentation, Inc.

K number K873068

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CCL 1987-06-15

MODEL TPC-1A OXYGEN ANALYZER

Applicant Medical, Inc.

K number K872001

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CCL 1987-06-05

M-2 OXYGEN/TEMPERATURE MONITOR

Applicant Bio-Med Devices, Inc.

K number K871337

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CCL 1986-11-13

MODEL T-1 OXYGEN ANALYZER

Applicant Chrysalis Systems, Inc.

K number K863158

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CCL 1986-10-15

MODEL A-1 OXYGEN ANALYZER

Applicant Medical, Inc.

K number K863806

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CCL 1986-06-19

NO. 100352 GALVANIC OXYGEN SENSOR

Applicant Vascular Technology Incorporated

K number K862113

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CCL 1986-05-02

SERVO GAS MONITOR 120

Applicant Siemens Elema AB

K number K861625

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CCL 1985-12-11

EMERSON MODEL 3MV-OAA ALARM MODULE

Applicant J. H. Emerson Co.

K number K854799

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CCL 1985-11-27

VICKERS MEDICAL MODEL 273 OXYGEN MONITOR

Applicant Vickers , Ltd.

K number K854599

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CCL 1985-10-29

DMA OXYGEN MONITOR

Applicant Ferguson Medical

K number K852823

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CCL 1985-07-31

OHMEDA 5120 OXYGEN MONITOR

Applicant Ohmeda Medical

K number K853082

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CCL 1985-06-20

VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR

Applicant Vascular Technology Incorporated

K number K852275

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CCL 1984-10-12

O2 TEST

Applicant Erich Jaeger, Inc.

K number K843847

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CCL 1984-04-05

ENGSTROM ELIZA DUO CO2 & O2 ANALYZ

Applicant Gambro, Inc.

K number K840645

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CCL 1984-04-02

MONITOR 5590- ANALYZER 5595EC

Applicant Hudson Oxygen Therapy Sales Co.

K number K840565

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CCL 1984-02-27

NOVOX OXYGEN ANALYZER 400

Applicant Novametrix Medical Systems, Inc.

K number K840392

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CCL 1984-02-17

OXYGEN ANALYZER 200

Applicant Salter Labs

K number K840361

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CCL 1983-12-16

OXYGEN MONITOR/CONTROLLER

Applicant Oxequip Health Ind.

K number K833496

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CCL 1983-12-12

MINI OX II

Applicant Catalyst Research Corp.

K number K833995

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CCL 1983-09-12

BIO-TEK PERCENT OXYGEN MONITOR 74222

Applicant Bio-Tek Instruments, Inc.

K number K831522

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CCL 1983-05-09

OXYMED

Applicant Draeger Medical, Inc.

K number K831238

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CCL 1983-03-24

OXYGEN MONITOR OHIO 5100

Applicant Airco/Ohio Medical Products

K number K830446

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CCL 1983-02-09

OPTION A02 MODEL 15202A

Applicant Hewlett-Packard Co.

K number K830124

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CCL 1983-01-05

RESPIRATORY GAS ANALYZER

Applicant Thoratec Laboratories Corp.

K number K823449

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CCL 1982-12-09

OXYGEN MONITOR IL 408

Applicant Instrumentation Laboratory CO

K number K823374

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CCL 1982-12-07

YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP

Applicant Yellow Springs Instrument Co., Inc.

K number K823232

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CCL 1982-12-07

YSI #2600 MULTI-CHANNEL DUAL-DISPLAY

Applicant Yellow Springs Instrument Co., Inc.

K number K823231

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CCL 1982-10-04

MK 808 SERIES NASAL OXYGEN SAMPLER

Applicant Instrumentation Industries, Inc.

K number K822608

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