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510(k) K211918

Device
iCOquit® Smokerlyzer®
Applicant
Bedfont Scientific, Ltd.
510(k) number
K211918
Product code
CCJ
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-21
Date received
2021-06-21
Regulation
868.1430
Classification name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
Louise Bateman
Address
Station Rd., Harrietsham Maidstone, Kent GB ME17 1JA ME17 1JA

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CCJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201206Pivot Breath SensorCarrot, Inc.2021-06-30
K173238ToxCOBedfont Scientific, Ltd.2019-04-04
K171129CO Check Pro, CO ScreenMD Diagnostics Limited2018-03-02
K171408Carbon Monoxide Breath Sensor System (COBSS)Carrot Sense, Inc.2017-09-29
K151107CoSense ETCO MonitorCapnia, Inc.2015-07-22
K130036COSENSE CO MONITORCapnia, Inc.2014-01-14
K121768COSENSECapnia, Inc.2012-10-31
K082315EC50 MICRO+ SMOKERLYZERBedfont Scientific, Ltd.2010-02-01
K080278TABATABA COTESTERFim Medical2008-11-28
K070259EC50 TOXCO+ BREATH CARBON MONOXIDE MONITORBedfont Scientific, Ltd.2008-02-21
K000962PICO SMOKERLYZER, MODEL EC-50Bedfont Scientific, Ltd.2000-04-20
K950197MICROCOMicro Direct, Inc.1996-10-17
K952694CO BREATH ANALYSIS MODULE & MONOXOL IIBacharach, Inc.1996-01-29
K904633SPIROLOOP, MODIFICATIONPneumedics, Inc.1991-03-12
K902113VITALOGRAPH - BREATHCO MONITORMcneill Intl., Inc.1990-10-26