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
K832655 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ECOLYZER #200/COHB ANALYZER SYS 09/26/1983
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
K892841 BEDFONT TECHNICAL INSTRUMENTS LTD. BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR 10/05/1989
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
K171408 Carrot Sense, Inc. Carbon Monoxide Breath Sensor System (COBSS) 09/29/2017
K781746 CATALYST RESEARCH CORP. MINICO 12/05/1978
K843845 ERICH JAEGER, INC. CO TEST 10/12/1984
K080278 FIM MEDICAL TABATABA COTESTER 11/28/2008
K760169 HEWLETT-PACKARD CO. DIFFUSION SYSTEM, SINGLE-BREATH (47404A) 07/20/1976
K833739 INSTRUMENTARIUM CORP. CD-102 CARBON DIOXIDE ANALYZER/RECOR 12/16/1983
K902113 MCNEILL INTL., INC. VITALOGRAPH - BREATHCO MONITOR 10/26/1990
K171129 MD Diagnostics Limited CO Check Pro, CO Screen 03/02/2018
K950197 MICRO DIRECT, INC. MICROCO 10/17/1996
K781871 OHIO MEDICAL PRODUCTS DIFFUSION OPTION, OMNI-LAB 01/02/1979
K904633 PNEUMEDICS, INC. SPIROLOOP, MODIFICATION 03/12/1991
K802891 SHERWOOD MEDICAL CO. ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT 12/19/1980
K900322 SPIROMETRICS, INC. CO/CMD-1 04/30/1990
K863420 VITALOGRAPH LTD. VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR 01/15/1987
K892524 VITALOGRAPH LTD. VITALOGRAPH-BREATHCO MONITOR 05/05/1989


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