Product Code: CCK
FDA class 2
21 CFR 868.1400
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Anesthesiology
The Gaseous-Phase Carbon-Dioxide Analyzer is an anesthesiology device that measures the concentration of carbon dioxide in the gas phase of a breathing circuit, used to monitor end-tidal CO2 levels and assess adequacy of ventilation during anesthesia and intensive care. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CCK, regulated under 21 CFR 868.1400, within the Anesthesiology medical specialty. This device is eligible for third-party review.
510(k)s
302
FEI Numbers
204
Registration Numbers
204
Unique Applicants
165
Years Active
48
Basic Information
- Product Code
- CCK
- Device Class
- FDA class 2
- Regulation Number
- 868.1400
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 302 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243956 | TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) | Jun 10, 2025 | Substantially Equivalent | Nihon Kohden Corporation |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line | Jun 04, 2025 | Substantially Equivalent | Barbaras Development Inc. |
| K240937 | AIM (N/A) | Dec 16, 2024 | Substantially Equivalent | Inventeur, LLC |
| K230915 | AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask | Nov 12, 2024 | Substantially Equivalent | Vyaire Medical, Inc. |
| K222511 | Oxy2Pro | Nov 21, 2023 | Substantially Equivalent | Southmedic Inc. |
| K213767 | Endure ETCO2/02 Nasal Cannula | Sep 12, 2023 | Substantially Equivalent | Endure Industries Inc |
| K221118 | CO2 Mainstream Sensor | Apr 05, 2023 | Substantially Equivalent | Draegerwerk AG & Co. KGaA |
| K210112 | XChange Device, XChange System | Jan 30, 2023 | Substantially Equivalent | Pneuma Therapeutics, Inc. |
| K220533 | Endoscopy Oxygen Mask | Nov 16, 2022 | Substantially Equivalent | Engineered Medical Systems Inc. |
| K213911 | Microstream CO2 NanoPod | Jul 29, 2022 | Substantially Equivalent | Covidien LLC |
| K213518 | CARESCAPE CO2 Microstream parameter | Apr 12, 2022 | Substantially Equivalent | Covidien llc |
| K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories | Oct 21, 2021 | Substantially Equivalent | GE Healthcare Finland Oy |
| K203762 | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector | Sep 17, 2021 | Substantially Equivalent | Covidien |
| K201590 | EMMA Capnograph | Mar 29, 2021 | Substantially Equivalent | Masimo Corporation |
| K210019 | Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ | Mar 04, 2021 | Substantially Equivalent | Unimed Medical Supplies, Inc. |
| K192488 | CO2 Sidestream Module | May 22, 2020 | Substantially Equivalent | Beijing Kingst Commercial & Trade Co.,Ltd. |
| K192446 | CO2 Mainstream Module | May 21, 2020 | Substantially Equivalent | Beijing Kingst Commercial & Trade Co.,Ltd. |
| K200594 | Capnostream 35 Portable Respiratory Monitor | Apr 27, 2020 | Substantially Equivalent | Oridion Medical 1987 Ltd. |
| K192563 | Altera gas Sampling Lines | Jan 17, 2020 | Substantially Equivalent | Meditera Tibbi Malzeme San. ve Tic. A.S. |
| K190824 | Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric | Dec 18, 2019 | Substantially Equivalent | Bluepoint Medical GmbH & Co. KG |
| K182362 | MaxCap Ped and MaxCap Neo | May 23, 2019 | Substantially Equivalent | Maxtec, LLC |
| K183394 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO | May 01, 2019 | Substantially Equivalent | GE Healthcare Finland Oy |
| K181624 | Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line | Mar 22, 2019 | Substantially Equivalent | Oridion Medical 1987 Ltd. |
| K181467 | Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line | Feb 08, 2019 | Substantially Equivalent | Oridion Medical 1987 Ltd. |
| K181981 | CO2 Sampling Line | Feb 06, 2019 | Substantially Equivalent | Tylenol Medical Instruments Co., Ltd |
| K180902 | MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly | Jan 11, 2019 | Substantially Equivalent | MediPines Corporation |
| K170820 | Capnograph and Oximeter | Jul 18, 2018 | Substantially Equivalent | CMI Health Inc. |
| K173147 | SuperNO2VA Et Device | Jun 20, 2018 | Substantially Equivalent | Revolutionary Medical Devices, Inc. |
| K171828 | ETCO2 Sensor | May 31, 2018 | Substantially Equivalent | Orantech Inc. |
| K171678 | Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable | Apr 30, 2018 | Substantially Equivalent | Vyaire Medical, Inc. |
| K172365 | Panoramic Oxygen Mask (POM) | Apr 19, 2018 | Substantially Equivalent | Pom Medical, LLC |
| K171235 | OmniCap | Jan 04, 2018 | Substantially Equivalent | Respirion, Inc. |
| K172904 | IntelliVue Capnography Extension, IntelliVue Microstream Extension | Dec 26, 2017 | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH |
| K171765 | Nihon Kohden CO2 Monitor | Oct 11, 2017 | Substantially Equivalent | Nihon Kohden Corporation |
| K171028 | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories | Aug 17, 2017 | Substantially Equivalent | GE Healthcare Finland OY |
| K161250 | OC-FLEX Flexible IntraOral Cannula | Mar 17, 2017 | Substantially Equivalent | Venture Therapeutics, Inc. |
| K161860 | TG-970P CO2 Sensor Kit | Feb 24, 2017 | Substantially Equivalent | NIHON KOHDEN CORPORATION |
| K162343 | Westmed Gas Sampling Cannula with O2 delivery | Dec 14, 2016 | Substantially Equivalent | WESTMED, INC. |
| K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines | Mar 10, 2016 | Substantially Equivalent | Salter Labs |
| K150272 | Capnostream 35 Portable Respiratory Monitor | Jul 17, 2015 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K150245 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX | Jul 17, 2015 | Substantially Equivalent | GE HEALTHCARE FINLAND OY |
| K143127 | CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style | Feb 13, 2015 | Substantially Equivalent | DISPO-MED (MALAYSIA) SDN BHD |
| K143469 | SOFTECH Plus ETCO2 Cannula | Feb 12, 2015 | Substantially Equivalent | TELEFLEX MEDICAL, INC. |
| K143150 | CO2 monitoring line with and without in-line filter | Feb 05, 2015 | Substantially Equivalent | BESMED HEALTH BUSINESS CORP. |
| K142467 | IntelAir Nasal Airway Support System | Nov 24, 2014 | Substantially Equivalent | ABEON MEDICAL CORPORATION |
| K123690 | CAPNOSTREAM20P WITH HIFI C02 MONITORING | Aug 05, 2014 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K132946 | SOFTECH PLUS ETC02 CANNULA | Jun 04, 2014 | Substantially Equivalent | Teleflex Medical, Inc. |
| K133516 | CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER | Apr 30, 2014 | Substantially Equivalent | FLEXICARE |
| K140473 | DUALGUARD | Apr 10, 2014 | Substantially Equivalent | FLEXICARE MEDICAL LTD. |
| K133540 | FLOCAP | Mar 28, 2014 | Substantially Equivalent | MAXTEC, INC. |
| K140113 | O2 NASAL CANNULA WITH CO2 MONITORING | Mar 06, 2014 | Substantially Equivalent | FLEXICARE MEDICAL LTD. |
| K131506 | AIRWAY SUPPORT SYSTEM / AIRPORT | Mar 06, 2014 | Substantially Equivalent | ABEON MEDICAL CORPORATION |
| K131410 | CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE), | Jan 13, 2014 | Substantially Equivalent | SOUTHMEDIC, INC. |
| K133806 | M1 CAPNOGRAPHY MASK | Dec 31, 2013 | Substantially Equivalent | MONITOR MASK, INC. |
| K131339 | CAPNOMASK | Nov 25, 2013 | Substantially Equivalent | MEDIPLUS LTD. |
| K122214 | TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) | May 21, 2013 | Substantially Equivalent | NIHON KOHDEN CORP. |
| K130112 | CAPNO MODULE, 92517 | Mar 21, 2013 | Substantially Equivalent | SPACELABS HEALTHCARE |
| K122075 | DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER | Dec 20, 2012 | Substantially Equivalent | INTERSURGICAL, INC. |
| K121927 | MICROSTREAM FILTERLINE ICU | Nov 29, 2012 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K123043 | IRMA C02 MODEL 200101; IRMA AX 200601 | Oct 25, 2012 | Substantially Equivalent | PHASEIN AB |
| K112368 | CAPNOSTREAM20P WITH AI/ODI | Jul 19, 2012 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K121017 | CAPNOGRAPHY PAD (92516) | Jul 13, 2012 | Substantially Equivalent | SPACELABS HEALTHCARE |
| K112840 | CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR | Jul 13, 2012 | Substantially Equivalent | SEEBREATH AB |
| K120518 | END TIDAL CO2 NASAL CANNULA | May 04, 2012 | Substantially Equivalent | CAREFUSION |
| K110594 | GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS | Oct 28, 2011 | Substantially Equivalent | NIHON KOHDEN CORP. |
| K103604 | ISA CO2, ISA AX+, ISA OR+ | Apr 06, 2011 | Substantially Equivalent | PHASEIN AB |
| K094012 | CAPNOSTREAM20 WITH MICROMEDICO2 MODULE | May 12, 2010 | Substantially Equivalent | ORIDION CAPNOGRAPHY, INC. |
| K100941 | INFINITY MCABLE - MAINSTREAM CO2 | Apr 23, 2010 | Substantially Equivalent | DRAEGER MEDICAL AG & CO. KG |
| K093388 | SMART CAPNOLINE GUARDIAN | Mar 04, 2010 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K093525 | ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE | Dec 10, 2009 | Substantially Equivalent | VENTLAB CORP. |
| K083456 | NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P | Mar 02, 2009 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K083056 | NEO-STAT CO2 <KG | Feb 23, 2009 | Substantially Equivalent | MERCURY MEDICAL |
| K080527 | TWINGUARD WITH CAPNOGRAPH ACCESSORY | Oct 31, 2008 | Substantially Equivalent | TRAWAX PTY LIMITED |
| K081601 | VEO MULTIGAS MONITOR FOR POCKET PC | Sep 04, 2008 | Substantially Equivalent | PHASEIN AB |
| K063813 | VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA | Mar 26, 2008 | Substantially Equivalent | VENTLAB CORP. |
| K072813 | EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) | Dec 28, 2007 | Substantially Equivalent | PHASEIN AB |
| K072843 | YG-125T AND YG-135T NASAL ADAPTER | Nov 29, 2007 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K072220 | PEDI CO2 EASY | Aug 23, 2007 | Substantially Equivalent | Westmed, Inc. |
| K070128 | CO2 EASY | Feb 15, 2007 | Substantially Equivalent | Westmed, Inc. |
| K063167 | EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) | Feb 06, 2007 | Substantially Equivalent | PHASEIN AB |
| K062115 | CARBON DIOXIDE MONITOR, MODEL OLG-2800A | Dec 27, 2006 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K053204 | INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A | Feb 03, 2006 | Substantially Equivalent | DRAEGER MEDICAL AG & CO. KGAA |
| K053174 | LOFLO C5 CO2 SENSOR | Jan 12, 2006 | Substantially Equivalent | RESPIRONICS NOVAMETRIX LLC |
| K053063 | PRO-FLOW MULTIPURPOSE CANNULA | Dec 13, 2005 | Substantially Equivalent | PRO-TECH SERVICES, INC. |
| K052880 | DATEX-OHMEDA S/5 INTERFACE MODULE E-INT | Nov 02, 2005 | Substantially Equivalent | GE HEALTHCARE |
| K052582 | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES | Oct 14, 2005 | Substantially Equivalent | GE HEALTHCARE |
| K051857 | VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221 | Sep 15, 2005 | Substantially Equivalent | WEISSBURG ASSOCIATES |
| K052167 | DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES | Sep 08, 2005 | Substantially Equivalent | GE HEALTHCARE |
| K050066 | C-CO2 COLORIMETRIC CO2 INDICATOR | Mar 01, 2005 | Substantially Equivalent | MARQUEST MEDICAL PRODUCTS, INC. |
| K042665 | SMART BITEBLOC | Nov 23, 2004 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K042601 | CAPNOSTAT 5 | Nov 19, 2004 | Substantially Equivalent | RESPIRONICS NOVAMETRIX, INC. |
| K040875 | CAP-ONE, MODEL TG-920P | Oct 15, 2004 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K041956 | EMG - ESSENTIAL GAS MODULE, MODEL M1013A | Aug 09, 2004 | Substantially Equivalent | DRAEGET MEDICAL AG & CO. KGAA |
| K041450 | MODIFICATION TO NICO WITH MARS, MODEL 7300 | Jun 18, 2004 | Substantially Equivalent | RESPIRONICS NOVAMETRIX, INC. |
| K040847 | MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR | Jun 17, 2004 | Substantially Equivalent | DRAEGER MEDICAL, INC. |
| K040011 | POLARIS 2004 CAPNOGRAPH | May 13, 2004 | Substantially Equivalent | ORIDION LTD. |
| K031741 | MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 | Feb 09, 2004 | Substantially Equivalent | ALARIS MEDICAL SYSTEMS, INC. |
| K030886 | NICO WITH MARS, MODEL 7300 | Oct 07, 2003 | Substantially Equivalent | RESPIRONICS NOVAMETRIX, INC. |
| K030407 | ADVISOR, MODEL 9200 | Aug 19, 2003 | Substantially Equivalent | BCI, INC. |
| K031814 | STATCO2METER, MODEL 10-55372 | Aug 14, 2003 | Substantially Equivalent | MERCURY MEDICAL |
| K031411 | MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 | Jul 30, 2003 | Substantially Equivalent | MERCURY MEDICAL |
| K023820 | CO2 CLIP | May 07, 2003 | Substantially Equivalent | BREGAS AB |
| K023454 | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES | Apr 23, 2003 | Substantially Equivalent | DATEX-OHMEDA |
| K023579 | GAS SAMPLING LINES | Jan 28, 2003 | Substantially Equivalent | PROMEDIC, INC. |
| K021576 | MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 | Nov 04, 2002 | Substantially Equivalent | MERCURY MEDICAL |
| K020046 | MULTIGAS UNIT, MODEL AG-920RA | Jul 25, 2002 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K014211 | OXYARM CO2 | Jun 11, 2002 | Substantially Equivalent | SOUTHMEDIC, INC. |
| K012139 | VAMOS ANESTHETIC GAS MONITOR | Jan 17, 2002 | Substantially Equivalent | DRAEGER MEDICAL, INC. |
| K013845 | MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE | Nov 29, 2001 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K011536 | MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE | Nov 14, 2001 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K012395 | MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE | Aug 15, 2001 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K012394 | ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE | Aug 15, 2001 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K012391 | MAC-LINE CO2 NASAL CANNULA SAMPLE LINE | Aug 15, 2001 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K011050 | MICROSTREAM ORAL NASAL CANNULA FILTERLINE | May 04, 2001 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K010795 | CAPNOPROBE SL, MODEL 2000 | Apr 11, 2001 | Substantially Equivalent | OPTICAL SENSORS, INC. |
| K010024 | O2/CO2 NASAL FILTERLINE | Mar 14, 2001 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K003550 | INFINITY ETCO2 + RESPIRATORY MECHANICS POD | Mar 07, 2001 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K003982 | TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR | Jan 26, 2001 | Substantially Equivalent | MAGNETIC RESONANCE EQUIPMENT CORP. |
| K002163 | MICROSTREAM EXTERNAL BATTERY CHARGER | Jan 11, 2001 | Substantially Equivalent | ORIDION MEDICAL 1987 LTD. |
| K984579 | CAPNO PROBE A | Dec 21, 2000 | Substantially Equivalent | OPTICAL SENSORS, INC. |
| K001814 | DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES | Aug 23, 2000 | Substantially Equivalent | DATEX-OHMEDA |
| K000520 | C-IT | May 16, 2000 | Substantially Equivalent | BREGAS AB |
| K000712 | PORTABLE INTENSIVE CARE UNIT, MODEL PIC | Apr 27, 2000 | Substantially Equivalent | MEDICAL RESEARCH LABORATORIES, INC. |
| K993656 | DATEX-OHMEDA TONOMETRY MODULE M-TONO | Mar 15, 2000 | Substantially Equivalent | DATEX-OHMEDA, INC. |
| K992116 | SIEMEMNS INFINITY ETC02 POD | Jan 12, 2000 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K983864 | ETCO2 VITAL SIGNS MODULE | Oct 08, 1999 | Substantially Equivalent | MENNEN MEDICAL, INC. |
| K982969 | NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847 | Aug 12, 1999 | Substantially Equivalent | NONIN MEDICAL, INC. |
| K991086 | CAPNOCHECK II, MODEL 8400 | Jun 09, 1999 | Substantially Equivalent | BCI INTL., INC. |
| K990063 | NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES | Jun 09, 1999 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K983114 | MAGNATEK80 | Sep 22, 1998 | Substantially Equivalent | MAGNA ADVANCED TECHNOLOGIES, INC. |
| K982846 | MTEK-1400 | Sep 18, 1998 | Substantially Equivalent | MAGNA ADVANCED TECHNOLOGIES, INC. |
| K981114 | MICROCAP | Jun 25, 1998 | Substantially Equivalent | ORIDION MEDICAL LTD. |
| K980979 | FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE | Jun 12, 1998 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K973544 | VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER | May 26, 1998 | Substantially Equivalent | VACUMED, DIV. OF VACUMETRICS, INC. |
| K980384 | TRIP TONOMETRY CATHETER, 18F | May 01, 1998 | Substantially Equivalent | DATEX-ENGSTROM, INC. |
| K980327 | MICROSTREAM FILTERLINE ICU | Apr 16, 1998 | Substantially Equivalent | ORIDION MEDICAL LTD. |
| K980325 | MICROSTREAM NASAL CANNULA FILTERLINE | Apr 16, 1998 | Substantially Equivalent | ORIDION MEDICAL LTD. |
| K980324 | MICROSTREAM FILLERLINE OR/EMS | Apr 16, 1998 | Substantially Equivalent | ORIDION MEDICAL LTD. |
| K973984 | RAC 2A MODULE HOUSING | Jan 16, 1998 | Substantially Equivalent | MARQUETTE MEDICAL SYSTEMS, INC. |
| K971229 | CAPNOXYGEN MASK | Sep 23, 1997 | Substantially Equivalent | MEDSYS, INC. |
| K964961 | MODEL 405T WITH ETCO2 OPTION | May 14, 1997 | Substantially Equivalent | IVY BIOMEDICAL SYSTEMS, INC. |
| K964239 | COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER | May 09, 1997 | Substantially Equivalent | SPEGAS INDUSTRIES, LTD. |
| K970209 | CAPNOCHECK PLUS | Apr 18, 1997 | Substantially Equivalent | BCI INTL., INC. |
| K962638 | TONOCAP, TC-200 AND ACCESSORY CATHETERS | Apr 04, 1997 | Substantially Equivalent | INSTRUMENTARIUM CORP. |
| K954120 | MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR | Apr 02, 1997 | Substantially Equivalent | MAGNETIC RESONANCE EQUIPMENT CORP. |
| K964305 | NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES | Feb 19, 1997 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K963327 | TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 | Nov 20, 1996 | Substantially Equivalent | NOVAMETRIX MEDICAL SYSTEMS, INC. |
| K960972 | DISPOSABLE GAS SAMPLING INTERFACE KITS | Oct 18, 1996 | Substantially Equivalent | MARQUEST MEDICAL PRODUCTS, INC. |
| K961150 | DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA | Sep 10, 1996 | Substantially Equivalent | HUDSON RESPIRATORY CARE, INC. |
| K954402 | ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | May 22, 1996 | Substantially Equivalent | ICOR AB |
| K954632 | SIEMENS SC 9000 ETCO2 MODULE | Feb 05, 1996 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K953006 | AS/3 NETWORK LINK | Sep 27, 1995 | Substantially Equivalent | DATEX MEDICAL INSTRUMENTATION, INC. |
| K950044 | FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE | Sep 15, 1995 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K952325 | ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) | Jul 31, 1995 | Substantially Equivalent | ICOR AB |
| K944052 | RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR | Jul 07, 1995 | Substantially Equivalent | OHMEDA MEDICAL |
| K950387 | GEMINI | May 03, 1995 | Substantially Equivalent | SPEGAS INDUSTRIES, LTD. |
| K950388 | POLARIS | May 02, 1995 | Substantially Equivalent | SPEGAS INDUSTRIES, LTD. |
| K950581 | SMART ANESTHESIA MULTI-GAS (SAM) MODULE | Mar 29, 1995 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K951127 | HEWLETT-PACKARD MODEL M1026A ANESTHETIC GAS MODULE | Mar 24, 1995 | Substantially Equivalent | HEWLETT-PACKARD GMBH |
| K943977 | SMART ANESTHESIA MULTI-GAS (SAM) MODULE | Mar 23, 1995 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K943389 | SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM | Mar 17, 1995 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K944541 | HANDYPACK 911SC | Feb 22, 1995 | Substantially Equivalent | PACE TECH, INC. |
| K942849 | CAPNOSAT | Feb 21, 1995 | Substantially Equivalent | SPEGAS INDUSTRIES, LTD. |
| K942113 | CARBON DIOXIDE ANALYZER (MODEL CD-3A) | Feb 16, 1995 | Substantially Equivalent | AMETEK, INC. |
| K946044 | DISPOSABLE GAS SAMPLING LINES | Dec 27, 1994 | Substantially Equivalent | CATHETER RESEARCH, INC. |
| K941971 | 9100 MUTIGAS MONITOR | Nov 21, 1994 | Substantially Equivalent | BCI INTL., INC. |
| K941982 | CAPNOCHECK | Oct 17, 1994 | Substantially Equivalent | BCI, INC. |
| K941165 | COMET CAPNOGRAPH MODULE | Oct 06, 1994 | Substantially Equivalent | SPACELABS, INC. |
| K944400 | PEDI-CAP | Sep 27, 1994 | Substantially Equivalent | NELLCOR, INC. |
| K925701 | MINIPACK 911-STC | Aug 11, 1994 | Substantially Equivalent | PACE TECH, INC. |
| K935477 | AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD | Aug 01, 1994 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K942772 | A-200 MULTI-USE AIRWAY ADAPTER | Jul 25, 1994 | Substantially Equivalent | PRYON CORP. |
| K935272 | CAP 400 AT | Jul 13, 1994 | Substantially Equivalent | PRYON CORP. |
| K933284 | AS/3 TM NETWORK | Jul 11, 1994 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K942567 | MASS SPECTROMETRY MONITORING LINES AND CONNECTORS | Jun 10, 1994 | Substantially Equivalent | MED-PLASTICS INTL., INC. |
| K930524 | END TIDAL CO2 OPTION B | Feb 07, 1994 | Substantially Equivalent | MEDICAL DATA ELECTRONICS |
| K933707 | CAPNODIG | Oct 27, 1993 | Substantially Equivalent | SPEGAS INDUSTRIES, LTD. |
| K930250 | LOW DEAD SPACE ADAPTOR & REUASABLE AIRWAY ADAPTOR | Oct 15, 1993 | Substantially Equivalent | PRYON CORP. |
| K933980 | HP M1465A STANDARD AIRWAY ADAPTER | Sep 09, 1993 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K930559 | VITALMAX 800-C | Sep 03, 1993 | Substantially Equivalent | PACE TECH, INC. |
| K915494 | NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60 | Aug 06, 1993 | Substantially Equivalent | NELLCOR, INC. |
| K930957 | ZEFON GAS SAMPLING LINES | Jul 02, 1993 | Unknown | ZEFON MEDICAL PRODUCTS |
| K925484 | CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308 | Jun 22, 1993 | Substantially Equivalent | BRUEL & KJAER |
| K930866 | RASCAL II | May 13, 1993 | Substantially Equivalent | OHMEDA MEDICAL |
| K925424 | MEDICAL MANUFACTURING INC GAS SAMPLING LINES&CONN. | Apr 19, 1993 | Unknown | MEDICAL MANUFACTURERS, INC. |
| K921497 | PROPAQ MONITORS, MODIFICATION | Mar 23, 1993 | Substantially Equivalent | PROTOCOL SYSTEMS, INC. |
| K920915 | CAPNOMED 100 STAND-ALONE ETCO2 MODULE | Mar 23, 1993 | Substantially Equivalent | MENNEN MEDICAL, INC. |
| K924083 | 700/700-1 | Mar 10, 1993 | Substantially Equivalent | CITICARE SYSTEMS, INC. |
| K925167 | MASS SPECTROMETRY MONITORING LINE CONONECTORS | Jan 22, 1993 | Substantially Equivalent | MERIT MEDICAL SYSTEMS, INC. |
| K923305 | BATTERY PACKS | Dec 17, 1992 | Substantially Equivalent | ACCESS / GOD LOVES YOU |
| K913995 | VITALERT 3000 MONITORING SYSTEM | Nov 03, 1992 | Substantially Equivalent | DRAEGER MEDICAL, INC. |
| K921526 | DATASCOPE PASSPORT MONITOR WITH CO2 | Oct 14, 1992 | Substantially Equivalent | DATASCOPE CORP. |
| K920622 | RASCAL II | Oct 13, 1992 | Substantially Equivalent | OHMEDA MEDICAL |
| K920590 | OHMEDA MODEL 5250 RGM MONITOR | Aug 31, 1992 | Substantially Equivalent | OHMEDA MEDICAL |
| K911970 | NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICE | Aug 14, 1992 | Substantially Equivalent | NASORCAP ENT., INC. |
| K914337 | GAS SAMPLING INTERFACES | Mar 11, 1992 | Substantially Equivalent | VITAL SIGNS, INC. |
| K915228 | DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL | Feb 11, 1992 | Substantially Equivalent | HOSPITAK, INC. |
| K911193 | OHMEDA MODEL 4700 OXICAP | Aug 02, 1991 | Substantially Equivalent | OHMEDA MEDICAL |
| K911737 | MEDICAL ASSEMBLIES MASS SPECT MONIT LINE/CONNECT | Jul 11, 1991 | Substantially Equivalent | MEDICAL ASSEMBLIES, INC. |
| K904863 | MGA-IR SIDESTREAM PCO2 MODULE | Jun 19, 1991 | Substantially Equivalent | MARQUETTE GAS ANALYSIS CORP. |
| K904789 | SERIES 7000 CARBON DIOXIDE MODULE | May 22, 1991 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K910509 | PATIENT GAS SAMPLING LINE FOR OHMEDA 6000 | Apr 17, 1991 | Substantially Equivalent | INTERTECH RESOURCES, INC. |
| K910106 | DATASCOPE MULTINEX ID MONITOR | Mar 29, 1991 | Substantially Equivalent | DATASCOPE CORP. |
| K910019 | NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON | Mar 26, 1991 | Substantially Equivalent | NOVAMETRIX MEDICAL SYSTEMS, INC. |
| K905775 | SIEMENS ETCO2 CARTRIDGE | Mar 11, 1991 | Substantially Equivalent | SIEMENS MEDICAL ELECTRONICS |
| K903200 | MINICAP III CO2 DETECTOR | Sep 21, 1990 | Substantially Equivalent | MINE SAFETY APPLIANCES, CO. |
| K896652 | CAPNOMAC ULTIMA(TM) ANESTHESIA MONITOR | Sep 05, 1990 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K901861 | BIOCHEM 9100 MULTIGAS MONITOR | Jul 27, 1990 | Substantially Equivalent | BIOCHEM INTERNATIONAL, INC. |
| K901132 | SARA SATCAP | May 22, 1990 | Substantially Equivalent | PPG INDUSTRIES, INC. |
| K900291 | MASS SPECTROMETRY MONITORING LINES AND CONNECTORS | Mar 28, 1990 | Substantially Equivalent | F.L.W. PLASTICS, INC. |
| K900979 | GAS SAMPLING NASAL CANNULA | Mar 16, 1990 | Substantially Equivalent | GIBECK, INC. |
| K896737 | TYPE 9292 INTERFACE CAPNOGRAPH | Feb 28, 1990 | Substantially Equivalent | S & W MEDICO TEKNIK |
| K895001 | TYPE EXPIRED CO2 9270, CAPNOGRAPH | Feb 22, 1990 | Substantially Equivalent | S & W MEDICO TEKNIK |
| K896030 | HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02 | Dec 22, 1989 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K894691 | MODEL AO-800PA CO2 MODULE | Dec 22, 1989 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K895780 | OSCAROXY(TM) GAS MONITOR AND PULSE OXIMETER | Nov 29, 1989 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K894350 | SALTER LABS MODEL #4009 SAMPLE LINES | Oct 03, 1989 | Substantially Equivalent | SALTER LABS |
| K894429 | MODIFIED CLAIMS FOR FEF(TM) END-TIDAL CO2 DETECTOR | Sep 18, 1989 | Substantially Equivalent | FENEM, INC. |
| K890817 | OMNI-TRAK (PATIENT MONITOR) | Aug 10, 1989 | Substantially Equivalent | INVIVO RESEARCH, INC. |
| K891076 | CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR | Aug 02, 1989 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K893589 | MULTI-GAS ANALYZER (MGA) | Jul 27, 1989 | Substantially Equivalent | MARQUETTE GAS ANALYSIS CORP. |
| K892406 | MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA | Jul 24, 1989 | Substantially Equivalent | SALTER LABS |
| K894053 | 2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR | Jul 20, 1989 | Substantially Equivalent | FENEM, INC. |
| K890874 | BIOCHEM 520 BREATH INDICATOR | Jun 15, 1989 | Substantially Equivalent | BIOCHEM INTERNATIONAL, INC. |
| K890112 | ENGSTROM ELIZA + CO2 ANALYZER | Mar 15, 1989 | Substantially Equivalent | GAMBRO, INC. |
| K883090 | MINICAP TM 100 CAPNOMETER | Jan 30, 1989 | Substantially Equivalent | MINESAFETY APPLIANCES CO. |
| K884158 | THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER | Jan 17, 1989 | Substantially Equivalent | PPG INDUSTRIES, INC. |
| K881206 | CHRONAMED CM101 | Dec 05, 1988 | Substantially Equivalent | CHRONAMED CORP. |
| K884080 | MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR | Oct 21, 1988 | Substantially Equivalent | FENEM, INC. |
| K882885 | DATEX AIRWAY MONITOR | Oct 19, 1988 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K882748 | NORMOCAP 200 CAPNOMETER | Oct 19, 1988 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K883950 | MODIFIED TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER | Sep 29, 1988 | Substantially Equivalent | FENEM, INC. |
| K883821 | FEF(TM) END-TIDAL CO2 DETECTOR | Sep 26, 1988 | Substantially Equivalent | FENEM, INC. |
| K882661 | ACUMED 9000 ETCO(2) MONITOR | Aug 24, 1988 | Substantially Equivalent | ACUMED TECHNOLOGIES, INC. |
| K881002 | O.R. SARACAP | Aug 15, 1988 | Substantially Equivalent | PPG/APPLIED RESOURCES, INC. |
| K882172 | SARACAP AG | Jun 24, 1988 | Substantially Equivalent | PPG/APPLIED RESOURCES, INC. |
| K881093 | ICU SARACAP | Jun 24, 1988 | Substantially Equivalent | PPG/APPLIED RESOURCES, INC. |
| K873396 | KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281 | Jun 21, 1988 | Substantially Equivalent | KONTRON INSTRUMENTS, INC. |
| K873380 | VITALERT 1000 MONITORING SYSTEM | Apr 14, 1988 | Substantially Equivalent | DRAEGER MEDICAL, INC. |
| K874724 | SARA AGIE MONITOR | Mar 29, 1988 | Substantially Equivalent | PPG/APPLIED RESOURCES, INC. |
| K874754 | SARA DIGICAP | Mar 21, 1988 | Substantially Equivalent | PPG/APPLIED RESOURCES, INC. |
| K871828 | TED MODEL 760 | Feb 04, 1988 | Substantially Equivalent | TELEDYNE, INC. |
| K875268 | TMM MODEL 2500 CAPMONITOR | Jan 22, 1988 | Substantially Equivalent | TRAVERSE MEDICAL MONITORS |
| K873856 | BIOCHEM 9090 CAPNOGRAPH/SAO2 | Dec 17, 1987 | Substantially Equivalent | BIOCHEM INTERNATIONAL, INC. |
| K873959 | BIOCHEM 8800 CAPNOMETER | Dec 11, 1987 | Substantially Equivalent | BIOCHEM INTERNATIONAL, INC. |
| K874036 | MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY | Nov 06, 1987 | Substantially Equivalent | NOVAMETRIX MEDICAL SYSTEMS, INC. |
| K873149 | NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260 | Nov 06, 1987 | Substantially Equivalent | NOVAMETRIX MEDICAL SYSTEMS, INC. |
| K872760 | OSCAR(TM) PB255 OXIMETER CAPNOMETER | Sep 14, 1987 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K871253 | MASSTRON/MARQUEST MT-1000 GAS ANALYZER | Jun 15, 1987 | Substantially Equivalent | MASSTRON C/O BURDITT, BOWLES & RADZIUS, LTD. |
| K870858 | BADGWELL SAMPLING CATHETER | May 14, 1987 | Substantially Equivalent | DRYDEN CORP. |
| K871133 | BIOCHEM 8090 CAPNOGRAPH | Apr 21, 1987 | Substantially Equivalent | BIOCHEM INTERNATIONAL, INC. |
| K864199 | SALTER LABS #4001 ORAL NASAL CO2 SAMPLING CANNULA | Feb 10, 1987 | Substantially Equivalent | SALTER LABS |
| K864903 | MOD. 4006 ADU., OXY. DELIVE.-ORAL CO2 SAM. CANNULA | Jan 30, 1987 | Substantially Equivalent | SALTER LABS |
| K864902 | MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU. | Jan 28, 1987 | Substantially Equivalent | SALTER LABS |
| K863883 | MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA | Oct 27, 1986 | Substantially Equivalent | SALTER LABS |
| K863703 | SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE | Oct 15, 1986 | Substantially Equivalent | SALTER LABS |
| K863640 | MODIFIED GAS SAMPLING KIT | Oct 08, 1986 | Substantially Equivalent | RESPIRATORY SUPPORT PRODUCTS, INC. |
| K862880 | SARA RT | Aug 25, 1986 | Substantially Equivalent | ALLEGHANY INTL. MEDICAL TECHNOLOGY |
| K862605 | MODULAR MASS SPECTROMETER (M.S.) | Aug 13, 1986 | Substantially Equivalent | THE PERKIN-ELMER CORP. |
| K862559 | CARBOSTAT, CO2 ANALYZER | Jul 15, 1986 | Substantially Equivalent | ELM STREET DESIGNS |
| K862543 | DYNEX CO2/2000, CO2 ANALYZER | Jul 15, 1986 | Substantially Equivalent | ANALYTICAL PRODUCTS, INC. |
| K861398 | PRE-CHECK C02 DETECTOR | May 06, 1986 | Substantially Equivalent | ALLEGHANY INTL. MEDICAL TECHNOLOGY |
| K861213 | PB 254 IR - SPECTROMETER | Apr 04, 1986 | Substantially Equivalent | DATEX DIVISION INSTRUMENTARIUM CORP. |
| K860556 | SERIES 7050 CAPNOGRAPH | Feb 21, 1986 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K853396 | MULTICAP MULTIGAS CAPNOMETER PB252 | Aug 16, 1985 | Substantially Equivalent | INSTRUMENTARIUM CORP. |
| K852062 | SARACAP RESPIRATORY MONITOR | Aug 06, 1985 | Substantially Equivalent | ALLEGHANY INTL. MEDICAL TECHNOLOGY |
| K852463 | ANDROS ANALYZERS AIRWAY ADAPTER | Jul 08, 1985 | Substantially Equivalent | ANDROS ANALYZERS, INC. |
| K851658 | CAPNOMED | May 23, 1985 | Substantially Equivalent | DRAEGER MEDICAL, INC. |
| K851001 | SERIES 7000 END TIDAL CO2 MONITORING SYSTEM | May 13, 1985 | Substantially Equivalent | MARQUETTE ELECTRONICS, INC. |
| K850747 | TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR | Apr 02, 1985 | Substantially Equivalent | TRI-MED, INC. |
| K850746 | TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI | Apr 02, 1985 | Substantially Equivalent | TRI-MED, INC. |
| K850745 | TRI-MED MODEL 112 MOISTURE TRAP | Apr 02, 1985 | Substantially Equivalent | TRI-MED, INC. |
| K844010 | CPNOGARD CAPNOMETER 1250 | Feb 21, 1985 | Substantially Equivalent | NOVAMETRIX MEDICAL SYSTEMS, INC. |
| K843285 | TRI-MED 610 CAPNOSTAT GAS ANALYZER | Nov 13, 1984 | Substantially Equivalent | TRI-MED, INC. |
| K843970 | MODEL IM1074 END-TIDAL CO2 MODULE | Oct 24, 1984 | Substantially Equivalent | GOULD, INC. |
| K843844 | CO2 TEST | Oct 12, 1984 | Substantially Equivalent | ERICH JAEGER, INC. |
| K843599 | OHMEDA MODEL 5200 CO2 MONITOR | Oct 04, 1984 | Substantially Equivalent | OHMEDA MEDICAL |
| K842334 | LIFE MONITOR I | Aug 30, 1984 | Substantially Equivalent | ST. CROIX MEDICAL SYSTEMS, INC. |
| K842978 | 540 CAPNOGRAPH | Aug 24, 1984 | Substantially Equivalent | SPACELABS, INC. |
| K842325 | CAPNOMETER | Jun 26, 1984 | Substantially Equivalent | SENSORS, INC. |
| K841498 | C02 MONITOR-OIR-7101 | May 14, 1984 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K840966 | ANESTHETIC GAS MONITOR SYS | May 14, 1984 | Substantially Equivalent | MARQUEST MEDICAL PRODUCTS, INC. |
| K832005 | JP-2 RESPIRATORY MONITORING SYSTEM | Dec 29, 1983 | Substantially Equivalent | MORGAN ASSOCIATES, INC. |
| K833397 | TRI-MED 511 INFANT RESPIRATION MONITOR | Nov 28, 1983 | Substantially Equivalent | TRI-MED, INC. |
| K831447 | CAPNOMETER W/NEW AIRWAY ADAPTER 47210A | Nov 21, 1983 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K833060 | MODEL CD-3A-INCLUDING P-61B SENSOR | Nov 03, 1983 | Substantially Equivalent | APPLIED ELECTROCHEMISTRY, INC. |
| K832767 | ADVANTAGE #1700 | Nov 03, 1983 | Substantially Equivalent | THE PERKIN-ELMER CORP. |
| K831776 | CAPNOGRAPH | Oct 31, 1983 | Substantially Equivalent | DATASCOPE CORP. |
| K823049 | ENGSTROM ELIZA CO2 ANALYZER | Jan 12, 1983 | Substantially Equivalent | LKB INSTRUMENTS, INC. |
| K812643 | LIFESPAN CO2 | Nov 16, 1981 | Substantially Equivalent | BIOCHEM INTERNATIONAL, INC. |
| K810927 | RESPIRATORY INTENSIVE CARE SYSTEM (RICS) | Apr 14, 1981 | Substantially Equivalent | ALLIED HEALTHCARE PRODUCTS, INC. |
| K802459 | SIEMENS-ELEMA AB CO2 MONITOR 130 | Oct 23, 1980 | Substantially Equivalent | SIEMENS ELEMA AB |
| K800869 | MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA | May 28, 1980 | Substantially Equivalent | CAVITRON CORP. |
| K792155 | CO 2 METER | Nov 27, 1979 | Substantially Equivalent | BOEHRINGER LABORATORIES |
| K791570 | IL MODEL END TIDAL CO2 ANALYZER | Sep 04, 1979 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K782138 | MONITOR, BECKMAN LB-3CO2 | Jan 31, 1979 | Substantially Equivalent | BECKMAN INSTRUMENTS, INC. |
| K780324 | CAPNOMETER MODEL 47210A | Mar 14, 1978 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K780107 | ANALYZER-PLUG-IN, CO2 MODEL M 3104 | Jan 30, 1978 | Substantially Equivalent | ELECTRONICS FOR MEDICINE, INC. |
| K770968 | MONITOR, PATIENT, MODEL PM-I0N | Jun 08, 1977 | Substantially Equivalent | CAVITRON CORP. |
| K770721 | MONITORS, REMOTE, RMS III | Apr 28, 1977 | Substantially Equivalent | THE PERKIN-ELMER CORP. |
| K770713 | MONITOR, PATIENT, RESP. CARBON DIOXIDE | Apr 27, 1977 | Substantially Equivalent | CAVITRON CORP. |
| K770123 | EXERCISE RESPIRATORY GAS ANALYZER | Feb 01, 1977 | Substantially Equivalent | RESPIRONICS, INC. |
FEI Numbers
This FDA classification entry is associated with 204 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 204 registration numbers. Click on an entry to view related FDA registrations.