Atlas FDA

CCJ

28 FDA 510(k) clearances · Product code

168 daysmedian time to decision
537 days90th percentile
28clearances measured

FDA profile

Official device name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1430
Medical specialty
Anesthesiology
Flags
Third-party review eligible
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RecordFirmDate
CoSense ETCO Monitor (K253119)Capnia, Inc.2026-05-29
iCOquit® Smokerlyzer® (K211918)Bedfont Scientific, Ltd.2021-12-21
Pivot Breath Sensor (K201206)Carrot, Inc.2021-06-30
ToxCO (K173238)Bedfont Scientific, Ltd.2019-04-04
CO Check Pro, CO Screen (K171129)MD Diagnostics Limited2018-03-02
Carbon Monoxide Breath Sensor System (COBSS) (K171408)Carrot Sense, Inc.2017-09-29
CoSense ETCO Monitor (K151107)Capnia, Inc.2015-07-22
COSENSE CO MONITOR (K130036)Capnia, Inc.2014-01-14
COSENSE (K121768)Capnia, Inc.2012-10-31
EC50 MICRO+ SMOKERLYZER (K082315)Bedfont Scientific, Ltd.2010-02-01
TABATABA COTESTER (K080278)Fim Medical2008-11-28
EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR (K070259)Bedfont Scientific, Ltd.2008-02-21
PICO SMOKERLYZER, MODEL EC-50 (K000962)Bedfont Scientific, Ltd.2000-04-20
MICROCO (K950197)Micro Direct, Inc.1996-10-17
CO BREATH ANALYSIS MODULE & MONOXOL II (K952694)Bacharach, Inc.1996-01-29
SPIROLOOP, MODIFICATION (K904633)Pneumedics, Inc.1991-03-12
VITALOGRAPH - BREATHCO MONITOR (K902113)Mcneill Intl., Inc.1990-10-26
CO/CMD-1 (K900322)Spirometrics, Inc.1990-04-30
BEDFONT EC50 SMOKERLYZER CARBON MONOXIDE MONITOR (K892841)Bedfont Technical Instruments , Ltd.1989-10-05
VITALOGRAPH-BREATHCO MONITOR (K892524)Vitalograph , Ltd.1989-05-05
VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR (K863420)Vitalograph , Ltd.1987-01-15
CO TEST (K843845)Erich Jaeger, Inc.1984-10-12
CD-102 CARBON DIOXIDE ANALYZER/RECOR (K833739)Instrumentarium Corp.1983-12-16
ECOLYZER #200/COHB ANALYZER SYS (K832655)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-09-26
ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT (K802891)Sherwood Medical Co.1980-12-19
DIFFUSION OPTION, OMNI-LAB (K781871)Ohio Medical Products1979-01-02
MINICO (K781746)Catalyst Research Corp.1978-12-05
DIFFUSION SYSTEM, SINGLE-BREATH (47404A) (K760169)Hewlett-Packard Co.1976-07-20

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Every clearance here is in the API, with alerts when new ones post.