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FDA 510(k)

iCOquit® Smokerlyzer®

K-Number: K211918 · 2021-12-21

ApplicantBedfont Scientific, Ltd.
Decision Date2021-12-21
Product CodeCCJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

iCOquit® Smokerlyzer® is a medical device manufactured by Bedfont Scientific, Ltd.. It received FDA 510(k) clearance on 2021-12-21 under approval number K211918. The device is classified under product code CCJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iCOquit® Smokerlyzer®?

iCOquit® Smokerlyzer® is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Bedfont Scientific, Ltd.. The 510(k) number is K211918.

When was iCOquit® Smokerlyzer® approved by the FDA?

iCOquit® Smokerlyzer® received FDA 510(k) clearance on 2021-12-21, under approval number K211918.

What company makes iCOquit® Smokerlyzer®?

iCOquit® Smokerlyzer® is manufactured by Bedfont Scientific, Ltd..

What is the FDA product code for iCOquit® Smokerlyzer®?

The FDA product code for iCOquit® Smokerlyzer® is CCJ.

Other Devices by Bedfont Scientific, Ltd.

K173238ToxCO K203695NObreath®

Related Devices (Code: CCJ)

K171408Carbon Monoxide Breath Sensor System (COBSS)Carrot Sense, Inc. K171129CO Check Pro, CO ScreenMD Diagnostics Limited K173238ToxCOBedfont Scientific, Ltd. K201206Pivot Breath SensorCarrot, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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