Product code CCJ— Anesthesiology
CoSense ETCO Monitor
- Classification name
- Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- Device class
- Class 2
- Regulation
- 21 CFR 868.1430
- Advisory panel
- Anesthesiology
- Total cleared
- 28
- First cleared
- Most recent
Market context for product code CCJ
FDA has cleared devices under product code CCJ between 1976 and 2026, filed by 20 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2021
- 2019
- 2018
- 2017
- 2015
- 2014
- 2012
- 2010
- 2008
- 2000
- 1996
- 1991
- 1990
- 1989
Top applicants under product code CCJ
Recent clearances under product code CCJ
- K253119 — CoSense ETCO Monitor
- K211918 — iCOquit® Smokerlyzer®
- K201206 — Pivot Breath Sensor
- K173238 — ToxCO
- K171129 — CO Check Pro, CO Screen
- K171408 — Carbon Monoxide Breath Sensor System (COBSS)
- K151107 — CoSense ETCO Monitor
- K130036 — COSENSE CO MONITOR
- K121768 — COSENSE
- K082315 — EC50 MICRO+ SMOKERLYZER
- K080278 — TABATABA COTESTER
- K070259 — EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR
- K000962 — PICO SMOKERLYZER, MODEL EC-50
- K950197 — MICROCO
- K952694 — CO BREATH ANALYSIS MODULE & MONOXOL II
- K904633 — SPIROLOOP, MODIFICATION
- K902113 — VITALOGRAPH - BREATHCO MONITOR
- K900322 — CO/CMD-1
- K892841 — BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR
- K892524 — VITALOGRAPH-BREATHCO MONITOR
- K863420 — VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR
- K843845 — CO TEST
- K833739 — CD-102 CARBON DIOXIDE ANALYZER/RECOR
- K832655 — ECOLYZER #200/COHB ANALYZER SYS
- K802891 — ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT
- K781871 — DIFFUSION OPTION, OMNI-LAB
- K781746 — MINICO
- K760169 — DIFFUSION SYSTEM, SINGLE-BREATH (47404A)
Data sourced from openFDA. This site is unofficial and independent of the FDA.