Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
The Gaseous-Phase Carbon-Monoxide Analyzer is an anesthesiology device that measures the concentration of carbon monoxide in the gas phase of a breathing system, used to detect dangerous levels of CO in inspired gases and protect patients from carbon monoxide exposure. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CCJ, regulated under 21 CFR 868.1430, within the Anesthesiology medical specialty. This device is eligible for third-party review.
Basic Information
- Product Code
- CCJ
- Device Class
- FDA class 2
- Regulation Number
- 868.1430
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 27 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K211918 | iCOquit® Smokerlyzer® | Dec 21, 2021 | Substantially Equivalent | Bedfont Scientific Ltd |
| K201206 | Pivot Breath Sensor | Jun 30, 2021 | Substantially Equivalent | Carrot Inc. |
| K173238 | ToxCO | Apr 04, 2019 | Substantially Equivalent | Bedfont Scientific Ltd |
| K171129 | CO Check Pro, CO Screen | Mar 02, 2018 | Substantially Equivalent | MD Diagnostics Limited |
| K171408 | Carbon Monoxide Breath Sensor System (COBSS) | Sep 29, 2017 | Substantially Equivalent | Carrot Sense, Inc. |
| K151107 | CoSense ETCO Monitor | Jul 22, 2015 | Substantially Equivalent | Capnia Inc |
| K130036 | COSENSE CO MONITOR | Jan 14, 2014 | Substantially Equivalent | Capnia, Inc. |
| K121768 | COSENSE | Oct 31, 2012 | Substantially Equivalent | Capnia, Inc. |
| K082315 | EC50 MICRO+ SMOKERLYZER | Feb 01, 2010 | Substantially Equivalent | BEDFONT SCIENTIFIC LTD. |
| K080278 | TABATABA COTESTER | Nov 28, 2008 | Substantially Equivalent | FIM MEDICAL |
| K070259 | EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR | Feb 21, 2008 | Substantially Equivalent | BEDFONT SCIENTIFIC LTD. |
| K000962 | PICO SMOKERLYZER, MODEL EC-50 | Apr 20, 2000 | Substantially Equivalent | BEDFONT SCIENTIFIC LTD. |
| K950197 | MICROCO | Oct 17, 1996 | Substantially Equivalent | MICRO DIRECT, INC. |
| K952694 | CO BREATH ANALYSIS MODULE & MONOXOL II | Jan 29, 1996 | Substantially Equivalent | BACHARACH, INC. |
| K904633 | SPIROLOOP, MODIFICATION | Mar 12, 1991 | Substantially Equivalent | PNEUMEDICS, INC. |
| K902113 | VITALOGRAPH - BREATHCO MONITOR | Oct 26, 1990 | Substantially Equivalent | MCNEILL INTL., INC. |
| K900322 | CO/CMD-1 | Apr 30, 1990 | Substantially Equivalent | SPIROMETRICS, INC. |
| K892841 | BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR | Oct 05, 1989 | Substantially Equivalent | BEDFONT TECHNICAL INSTRUMENTS LTD. |
| K892524 | VITALOGRAPH-BREATHCO MONITOR | May 05, 1989 | Substantially Equivalent | VITALOGRAPH LTD. |
| K863420 | VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR | Jan 15, 1987 | Substantially Equivalent | VITALOGRAPH LTD. |
| K843845 | CO TEST | Oct 12, 1984 | Substantially Equivalent | ERICH JAEGER, INC. |
| K833739 | CD-102 CARBON DIOXIDE ANALYZER/RECOR | Dec 16, 1983 | Substantially Equivalent | INSTRUMENTARIUM CORP. |
| K832655 | ECOLYZER #200/COHB ANALYZER SYS | Sep 26, 1983 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K802891 | ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT | Dec 19, 1980 | Substantially Equivalent | SHERWOOD MEDICAL CO. |
| K781871 | DIFFUSION OPTION, OMNI-LAB | Jan 02, 1979 | Substantially Equivalent | OHIO MEDICAL PRODUCTS |
| K781746 | MINICO | Dec 05, 1978 | Substantially Equivalent | CATALYST RESEARCH CORP. |
| K760169 | DIFFUSION SYSTEM, SINGLE-BREATH (47404A) | Jul 20, 1976 | Substantially Equivalent | HEWLETT-PACKARD CO. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.