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® | December 21, 2021 |
| K201206 | carrot | Pivot Breath Sensor | June 30, 2021 |
| K173238 | bedfont scientific | ToxCO | April 4, 2019 |
| K171129 | md diagnostics limited | CO Check Pro, CO Screen | March 2, 2018 |
| K171408 | carrot sense | Carbon Monoxide Breath Sensor System (COBSS) | September 29, 2017 |
| K151107 | capnia | CoSense ETCO Monitor | July 22, 2015 |
| K130036 | capnia | COSENSE CO MONITOR | January 14, 2014 |
| K121768 | capnia | COSENSE | October 31, 2012 |
| K082315 | bedfont scientific | EC50 MICRO+ SMOKERLYZER | February 1, 2010 |
| K080278 | fim medical | TABATABA COTESTER | November 28, 2008 |
| K070259 | bedfont scientific | EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR | February 21, 2008 |
| K000962 | bedfont scientific | PICO SMOKERLYZER, MODEL EC-50 | April 20, 2000 |
| K950197 | micro direct | MICROCO | October 17, 1996 |
| K952694 | bacharach | CO BREATH ANALYSIS MODULE & MONOXOL II | January 29, 1996 |
| K904633 | pneumedics | SPIROLOOP, MODIFICATION | March 12, 1991 |
| K902113 | mcneill intl | VITALOGRAPH - BREATHCO MONITOR | October 26, 1990 |
| K900322 | spirometrics | CO/CMD-1 | April 30, 1990 |
| K892841 | bedfont technical instruments | BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR | October 5, 1989 |
| K892524 | vitalograph | VITALOGRAPH-BREATHCO MONITOR | May 5, 1989 |