Product code CCJ
- Device name
- Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1430
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211918 | iCOquit® Smokerlyzer® | Bedfont Scientific, Ltd. | 2021-12-21 |
| K201206 | Pivot Breath Sensor | Carrot, Inc. | 2021-06-30 |
| K173238 | ToxCO | Bedfont Scientific, Ltd. | 2019-04-04 |
| K171129 | CO Check Pro, CO Screen | MD Diagnostics Limited | 2018-03-02 |
| K171408 | Carbon Monoxide Breath Sensor System (COBSS) | Carrot Sense, Inc. | 2017-09-29 |
| K151107 | CoSense ETCO Monitor | Capnia, Inc. | 2015-07-22 |
| K130036 | COSENSE CO MONITOR | Capnia, Inc. | 2014-01-14 |
| K121768 | COSENSE | Capnia, Inc. | 2012-10-31 |
| K082315 | EC50 MICRO+ SMOKERLYZER | Bedfont Scientific, Ltd. | 2010-02-01 |
| K080278 | TABATABA COTESTER | Fim Medical | 2008-11-28 |
| K070259 | EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR | Bedfont Scientific, Ltd. | 2008-02-21 |
| K000962 | PICO SMOKERLYZER, MODEL EC-50 | Bedfont Scientific, Ltd. | 2000-04-20 |
| K950197 | MICROCO | Micro Direct, Inc. | 1996-10-17 |
| K952694 | CO BREATH ANALYSIS MODULE & MONOXOL II | Bacharach, Inc. | 1996-01-29 |
| K904633 | SPIROLOOP, MODIFICATION | Pneumedics, Inc. | 1991-03-12 |
| K902113 | VITALOGRAPH - BREATHCO MONITOR | Mcneill Intl., Inc. | 1990-10-26 |
| K900322 | CO/CMD-1 | Spirometrics, Inc. | 1990-04-30 |
| K892841 | BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR | Bedfont Technical Instruments , Ltd. | 1989-10-05 |
| K892524 | VITALOGRAPH-BREATHCO MONITOR | Vitalograph , Ltd. | 1989-05-05 |
| K863420 | VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR | Vitalograph , Ltd. | 1987-01-15 |
| K843845 | CO TEST | Erich Jaeger, Inc. | 1984-10-12 |
| K833739 | CD-102 CARBON DIOXIDE ANALYZER/RECOR | Instrumentarium Corp. | 1983-12-16 |
| K832655 | ECOLYZER #200/COHB ANALYZER SYS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-09-26 |
| K802891 | ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT | Sherwood Medical Co. | 1980-12-19 |
| K781871 | DIFFUSION OPTION, OMNI-LAB | Ohio Medical Products | 1979-01-02 |
| K781746 | MINICO | Catalyst Research Corp. | 1978-12-05 |
| K760169 | DIFFUSION SYSTEM, SINGLE-BREATH (47404A) | Hewlett-Packard Co. | 1976-07-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00858481006024 | CO Sensor Module | Capnia, INC. | 2026-05-06 |
| 00858481006055 | CoSense Precision Sampling Set | Capnia, INC. | 2026-05-06 |
| 05060246860238 | D-Piece™ | BEDFONT SCIENTIFIC LIMITED | 2026-03-17 |
| 05060246860474 | SteriBreath™ Eco | BEDFONT SCIENTIFIC LIMITED | 2026-03-17 |
| 14250892908929 | Jaeger | Jaeger Medical GmbH | 2025-11-24 |
| 05060246860429 | iCO Quit Smokerlyzer | BEDFONT SCIENTIFIC LIMITED | 2022-01-06 |
| 15099169297507 | BreathCO | VITALOGRAPH (IRELAND) LIMITED | 2021-03-11 |
| 06944904098463 | Sidestream CO2 module(FDA)II | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-10 |
| 06944904098456 | IBP_CO_SidestreamCO2 module(FDA/FJ)II | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-10 |
| 06944904098449 | IBP_CO_SidestreamCO2 module(FDA)II | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-10 |
| 06944904098432 | Sidestream CO2 module(FDA/FJ)II | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-10 |
| 06936415902674 | 1-Slot CO2 Module w/ kit (Neo) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-10 |
| 06936415902759 | 1-Slot CO2/O2 Module w/ kit (Neo) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-10 |
| 06944904096803 | ORIDION CO2 mod upgrd kit,intl | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-07 |
| 06944904098784 | 115-046935-00 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-06 |
| 06944904096810 | single CO2 Module(Neonate accessory kit) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-06 |
| 06944904096759 | ORIDION CO2(Package/no accessory) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-06 |
| 06944904096698 | single CO2 Module(accessory kit) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-06 |
| 05060246860030 | ToxCO | BEDFONT SCIENTIFIC LIMITED | 2020-03-12 |
| 05060246860047 | Smokerlyzer | BEDFONT SCIENTIFIC LIMITED | 2020-03-12 |
| 14250892904129 | Vyaire | Jaeger Medical GmbH | 2019-05-28 |
| 00863571000318 | Pivot Breath Sensor | CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC. | 2019-04-25 |
| 08635710003014 | Pivot Breath Sensor | CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC. | 2019-04-25 |
| 14250892901838 | Micro Medical | Jaeger Medical GmbH | 2018-05-11 |
| 00863571000301 | Carbon Monoxide Breath Sensor | CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC. | 2017-10-27 |
| 08635710003007 | Carbon Monoxide Breath Sensor | CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC. | 2017-10-27 |
| 03760253450287 | TRAPPER | FIM MEDICAL | 2017-09-15 |
| 03760253450294 | TABATABA V2 | FIM MEDICAL | 2017-09-15 |
| 03760253450263 | Pipette | FIM MEDICAL | 2017-09-15 |
| 15099196297501 | BreathCO | VITALOGRAPH (IRELAND) LIMITED | 2017-02-15 |