CCJ — Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase Class II
FDA Device Classification
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 |
|---|
| 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 |
| K863420 | vitalograph | VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR | January 15, 1987 |