FDA 510(k) Applications for Medical Device Product Code "CCJ"
(Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase)

FDA 510(k) Number Applicant Device Name Decision Date
K952694 BACHARACH, INC. CO BREATH ANALYSIS MODULE & MONOXOL II 01/29/1996
K211918 Bedfont Scientific Ltd iCOquit« Smokerlyzer« 12/21/2021
K173238 Bedfont Scientific Ltd ToxCO 04/04/2019
K082315 BEDFONT SCIENTIFIC LTD. EC50 MICRO+ SMOKERLYZER 02/01/2010
K070259 BEDFONT SCIENTIFIC LTD. EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR 02/21/2008
K000962 BEDFONT SCIENTIFIC LTD. PICO SMOKERLYZER, MODEL EC-50 04/20/2000
K151107 Capnia Inc CoSense ETCO Monitor 07/22/2015
K121768 Capnia, Inc. COSENSE 10/31/2012
K130036 Capnia, Inc. COSENSE CO MONITOR 01/14/2014
K201206 Carrot Inc. Pivot Breath Sensor 06/30/2021
K171408 Carrot Sense, Inc. Carbon Monoxide Breath Sensor System (COBSS) 09/29/2017
K080278 FIM MEDICAL TABATABA COTESTER 11/28/2008
K171129 MD Diagnostics Limited CO Check Pro, CO Screen 03/02/2018
K950197 MICRO DIRECT, INC. MICROCO 10/17/1996


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