Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

FDA product code CCK · 293 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.1400
Review panel: AN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-02-01 – 2026-08-12

CCK 2001-11-14

MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE

Applicant Oridion Medical 1987 , Ltd.

K number K011536

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CCK 2001-08-15

MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE

Applicant Oridion Medical 1987 , Ltd.

K number K012395

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CCK 2001-08-15

ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE

Applicant Oridion Medical 1987 , Ltd.

K number K012394

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CCK 2001-08-15

MAC-LINE CO2 NASAL CANNULA SAMPLE LINE

Applicant Oridion Medical 1987 , Ltd.

K number K012391

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CCK 2001-05-04

MICROSTREAM ORAL NASAL CANNULA FILTERLINE

Applicant Oridion Medical 1987 , Ltd.

K number K011050

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CCK 2001-04-11

CAPNOPROBE SL, MODEL 2000

Applicant Optical Sensors, Inc.

K number K010795

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CCK 2001-03-14

O2/CO2 NASAL FILTERLINE

Applicant Oridion Medical 1987 , Ltd.

K number K010024

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CCK 2001-03-07

INFINITY ETCO2 + RESPIRATORY MECHANICS POD

Applicant Siemens Medical Solutions USA, Inc.

K number K003550

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CCK 2001-01-26

TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR

Applicant Magnetic Resonance Equipment Corp.

K number K003982

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CCK 2001-01-11

MICROSTREAM EXTERNAL BATTERY CHARGER

Applicant Oridion Medical 1987 , Ltd.

K number K002163

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CCK 2000-12-21

CAPNO PROBE A

Applicant Optical Sensors, Inc.

K number K984579

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CCK 2000-08-23

DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES

Applicant Datex-Ohmeda

K number K001814

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CCK 2000-05-16

C-IT

Applicant Bregas AB

K number K000520

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CCK 2000-04-27

PORTABLE INTENSIVE CARE UNIT, MODEL PIC

Applicant Medical Research Laboratories, Inc.

K number K000712

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CCK 2000-03-15

DATEX-OHMEDA TONOMETRY MODULE M-TONO

Applicant Datex-Ohmeda, Inc.

K number K993656

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CCK 2000-01-12

SIEMEMNS INFINITY ETC02 POD

Applicant Siemens Medical Solutions USA, Inc.

K number K992116

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CCK 1999-10-08

ETCO2 VITAL SIGNS MODULE

Applicant Mennen Medical, Inc.

K number K983864

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CCK 1999-08-12

NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847

Applicant Nonin Medical, Inc.

K number K982969

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CCK 1999-06-09

CAPNOCHECK II, MODEL 8400

Applicant Bci Intl., Inc.

K number K991086

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CCK 1999-06-09

NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES

Applicant Nihon Kohden America, Inc.

K number K990063

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CCK 1998-09-22

MAGNATEK80

Applicant Magna Advanced Technologies, Inc.

K number K983114

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CCK 1998-09-18

MTEK-1400

Applicant Magna Advanced Technologies, Inc.

K number K982846

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CCK 1998-06-25

MICROCAP

Applicant Oridion Medical , Ltd.

K number K981114

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CCK 1998-06-12

FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE

Applicant Fukuda Denshi USA, Inc.

K number K980979

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CCK 1998-05-26

VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER

Applicant Vacumed, Div. of Vacumetrics, Inc.

K number K973544

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CCK 1998-05-01

TRIP TONOMETRY CATHETER, 18F

Applicant Datex-Engstrom, Inc.

K number K980384

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CCK 1998-04-16

MICROSTREAM FILTERLINE ICU

Applicant Oridion Medical , Ltd.

K number K980327

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CCK 1998-04-16

MICROSTREAM NASAL CANNULA FILTERLINE

Applicant Oridion Medical , Ltd.

K number K980325

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CCK 1998-04-16

MICROSTREAM FILLERLINE OR/EMS

Applicant Oridion Medical , Ltd.

K number K980324

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CCK 1998-01-16

RAC 2A MODULE HOUSING

Applicant Marquette Medical Systems, Inc.

K number K973984

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CCK 1997-09-23

CAPNOXYGEN MASK

Applicant Medsys, Inc.

K number K971229

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CCK 1997-05-14

MODEL 405T WITH ETCO2 OPTION

Applicant Ivy Biomedical Systems, Inc.

K number K964961

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CCK 1997-05-09

COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER

Applicant Spegas Industries, Ltd.

K number K964239

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CCK 1997-04-18

CAPNOCHECK PLUS

Applicant Bci Intl., Inc.

K number K970209

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CCK 1997-04-04

TONOCAP, TC-200 AND ACCESSORY CATHETERS

Applicant Instrumentarium Corp.

K number K962638

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CCK 1997-04-02

MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR

Applicant Magnetic Resonance Equipment Corp.

K number K954120

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CCK 1997-02-19

NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES

Applicant Nihon Kohden America, Inc.

K number K964305

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CCK 1996-11-20

TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610

Applicant Novametrix Medical Systems, Inc.

K number K963327

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CCK 1996-10-18

DISPOSABLE GAS SAMPLING INTERFACE KITS

Applicant Marquest Medical Products, Inc.

K number K960972

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CCK 1996-09-10

DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA

Applicant Hudson Respiratory Care, Inc.

K number K961150

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CCK 1996-05-22

ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)

Applicant Icor AB

K number K954402

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CCK 1996-02-05

SIEMENS SC 9000 ETCO2 MODULE

Applicant Siemens Medical Solutions USA, Inc.

K number K954632

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CCK 1995-09-27

AS/3 NETWORK LINK

Applicant Datex Medical Instrumentation, Inc.

K number K953006

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CCK 1995-09-15

FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE

Applicant Fukuda Denshi USA, Inc.

K number K950044

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CCK 1995-07-31

ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)

Applicant Icor AB

K number K952325

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CCK 1995-07-07

RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR

Applicant Ohmeda Medical

K number K944052

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CCK 1995-05-03

GEMINI

Applicant Spegas Industries, Ltd.

K number K950387

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CCK 1995-05-02

POLARIS

Applicant Spegas Industries, Ltd.

K number K950388

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CCK 1995-03-29

SMART ANESTHESIA MULTI-GAS (SAM) MODULE

Applicant Marquette Electronics, Inc.

K number K950581

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CCK 1995-03-24

HEWLETT-PACKARD MODEL M1026A ANESTHETIC GAS MODULE

Applicant Hewlett-Packard GmbH

K number K951127

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CCK 1995-03-23

SMART ANESTHESIA MULTI-GAS (SAM) MODULE

Applicant Marquette Electronics, Inc.

K number K943977

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CCK 1995-03-17

SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM

Applicant Hewlett-Packard Co.

K number K943389

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CCK 1995-02-22

HANDYPACK 911SC

Applicant Pace Tech, Inc.

K number K944541

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CCK 1995-02-21

CAPNOSAT

Applicant Spegas Industries, Ltd.

K number K942849

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CCK 1995-02-16

CARBON DIOXIDE ANALYZER (MODEL CD-3A)

Applicant Ametek, Inc.

K number K942113

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CCK 1994-12-27

DISPOSABLE GAS SAMPLING LINES

Applicant Catheter Research, Inc.

K number K946044

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CCK 1994-11-21

9100 MUTIGAS MONITOR

Applicant Bci Intl., Inc.

K number K941971

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CCK 1994-10-17

CAPNOCHECK

Applicant Bci, Inc.

K number K941982

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CCK 1994-10-06

COMET CAPNOGRAPH MODULE

Applicant Spacelabs, Inc.

K number K941165

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CCK 1994-09-27

PEDI-CAP

Applicant Nellcor, Inc.

K number K944400

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CCK 1994-08-11

MINIPACK 911-STC

Applicant Pace Tech, Inc.

K number K925701

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CCK 1994-08-01

AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD

Applicant Datex Division Instrumentarium Corp.

K number K935477

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CCK 1994-07-25

A-200 MULTI-USE AIRWAY ADAPTER

Applicant Pryon Corp.

K number K942772

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CCK 1994-07-13

CAP 400 AT

Applicant Pryon Corp.

K number K935272

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CCK 1994-07-11

AS/3 TM NETWORK

Applicant Datex Division Instrumentarium Corp.

K number K933284

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CCK 1994-06-10

MASS SPECTROMETRY MONITORING LINES AND CONNECTORS

Applicant Med-Plastics Intl., Inc.

K number K942567

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CCK 1994-02-07

END TIDAL CO2 OPTION B

Applicant Medical Data Electronics

K number K930524

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CCK 1993-10-27

CAPNODIG

Applicant Spegas Industries, Ltd.

K number K933707

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CCK 1993-10-15

LOW DEAD SPACE ADAPTOR & REUASABLE AIRWAY ADAPTOR

Applicant Pryon Corp.

K number K930250

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CCK 1993-09-09

HP M1465A STANDARD AIRWAY ADAPTER

Applicant Hewlett-Packard Co.

K number K933980

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CCK 1993-09-03

VITALMAX 800-C

Applicant Pace Tech, Inc.

K number K930559

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CCK 1993-08-06

NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60

Applicant Nellcor, Inc.

K number K915494

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CCK 1993-07-02

ZEFON GAS SAMPLING LINES

Applicant Zefon Medical Products

K number K930957

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CCK 1993-06-22

CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308

Applicant Bruel & Kjaer

K number K925484

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CCK 1993-05-13

RASCAL II

Applicant Ohmeda Medical

K number K930866

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CCK 1993-04-19

MEDICAL MANUFACTURING INC GAS SAMPLING LINES&CONN.

Applicant Medical Manufacturers, Inc.

K number K925424

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CCK 1993-03-23

PROPAQ MONITORS, MODIFICATION

Applicant Protocol Systems, Inc.

K number K921497

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CCK 1993-03-23

CAPNOMED 100 STAND-ALONE ETCO2 MODULE

Applicant Mennen Medical, Inc.

K number K920915

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CCK 1993-03-10

700/700-1

Applicant Citicare Systems, Inc.

K number K924083

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CCK 1993-01-22

MASS SPECTROMETRY MONITORING LINE CONONECTORS

Applicant Merit Medical Systems, Inc.

K number K925167

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CCK 1992-12-17

BATTERY PACKS

Applicant Access / God Loves You

K number K923305

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CCK 1992-11-03

VITALERT 3000 MONITORING SYSTEM

Applicant Draeger Medical, Inc.

K number K913995

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CCK 1992-10-14

DATASCOPE PASSPORT MONITOR WITH CO2

Applicant Datascope Corp.

K number K921526

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CCK 1992-10-13

RASCAL II

Applicant Ohmeda Medical

K number K920622

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CCK 1992-08-31

OHMEDA MODEL 5250 RGM MONITOR

Applicant Ohmeda Medical

K number K920590

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CCK 1992-08-14

NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICE

Applicant Nasorcap Ent., Inc.

K number K911970

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CCK 1992-03-11

GAS SAMPLING INTERFACES

Applicant Vital Signs, Inc.

K number K914337

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CCK 1992-02-11

DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL

Applicant Hospitak, Inc.

K number K915228

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CCK 1991-08-02

OHMEDA MODEL 4700 OXICAP

Applicant Ohmeda Medical

K number K911193

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CCK 1991-07-11

MEDICAL ASSEMBLIES MASS SPECT MONIT LINE/CONNECT

Applicant Medical Assemblies, Inc.

K number K911737

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CCK 1991-06-19

MGA-IR SIDESTREAM PCO2 MODULE

Applicant Marquette Gas Analysis Corp.

K number K904863

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CCK 1991-05-22

SERIES 7000 CARBON DIOXIDE MODULE

Applicant Marquette Electronics, Inc.

K number K904789

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CCK 1991-04-17

PATIENT GAS SAMPLING LINE FOR OHMEDA 6000

Applicant Intertech Resources, Inc.

K number K910509

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CCK 1991-03-29

DATASCOPE MULTINEX ID MONITOR

Applicant Datascope Corp.

K number K910106

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CCK 1991-03-26

NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON

Applicant Novametrix Medical Systems, Inc.

K number K910019

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CCK 1991-03-11

SIEMENS ETCO2 CARTRIDGE

Applicant Siemens Medical Electronics

K number K905775

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CCK 1990-09-21

MINICAP III CO2 DETECTOR

Applicant Minesafety Appliances Co.

K number K903200

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CCK 1990-09-05

CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR

Applicant Datex Division Instrumentarium Corp.

K number K896652

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CCK 1990-07-27

BIOCHEM 9100 MULTIGAS MONITOR

Applicant Biochem International, Inc.

K number K901861

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CCK 1990-05-22

SARA SATCAP

Applicant Ppg Industries, Inc.

K number K901132

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