CCJ — Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase Class II
FDA product code CCJ covers "Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase", a Class II medical device regulated under 21 CFR 868.1430. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CCJ
- Device Class
- Class II
- Regulation Number
- 868.1430
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253119 | Capnia | CoSense ETCO Monitor | May 29, 2026 |
| K211918 | Bedfont Scientific | iCOquit® Smokerlyzer® | Dec 21, 2021 |
| K201206 | Carrot | Pivot Breath Sensor | Jun 30, 2021 |
| K173238 | Bedfont Scientific | ToxCO | Apr 4, 2019 |
| K171129 | Md Diagnostics Limited | CO Check Pro, CO Screen | Mar 2, 2018 |
| K171408 | Carrot Sense | Carbon Monoxide Breath Sensor System (COBSS) | Sep 29, 2017 |
| K151107 | Capnia | CoSense ETCO Monitor | Jul 22, 2015 |
| K130036 | Capnia | COSENSE CO MONITOR | Jan 14, 2014 |
| K121768 | Capnia | COSENSE | Oct 31, 2012 |
| K082315 | Bedfont Scientific | EC50 MICRO+ SMOKERLYZER | Feb 1, 2010 |
| K080278 | Fim Medical | TABATABA COTESTER | Nov 28, 2008 |
| K070259 | Bedfont Scientific | EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR | Feb 21, 2008 |
| K000962 | Bedfont Scientific | PICO SMOKERLYZER, MODEL EC-50 | Apr 20, 2000 |
| K950197 | Micro Direct | MICROCO | Oct 17, 1996 |
| K952694 | Bacharach | CO BREATH ANALYSIS MODULE & MONOXOL II | Jan 29, 1996 |
| K904633 | Pneumedics | SPIROLOOP, MODIFICATION | Mar 12, 1991 |
| K902113 | Mcneill Intl | VITALOGRAPH - BREATHCO MONITOR | Oct 26, 1990 |
| K900322 | Spirometrics | CO/CMD-1 | Apr 30, 1990 |
| K892841 | Bedfont Technical Instruments | BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR | Oct 5, 1989 |
| K892524 | Vitalograph | VITALOGRAPH-BREATHCO MONITOR | May 5, 1989 |