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FDA 510(k)

ToxCO

K-Number: K173238 · 2019-04-04

ApplicantBedfont Scientific, Ltd.
Decision Date2019-04-04
Product CodeCCJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ToxCO is a medical device manufactured by Bedfont Scientific, Ltd.. It received FDA 510(k) clearance on 2019-04-04 under approval number K173238. 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 ToxCO?

ToxCO is a medical device that received FDA 510(k) clearance on 2019-04-04. It is manufactured by Bedfont Scientific, Ltd.. The 510(k) number is K173238.

When was ToxCO approved by the FDA?

ToxCO received FDA 510(k) clearance on 2019-04-04, under approval number K173238.

What company makes ToxCO?

ToxCO is manufactured by Bedfont Scientific, Ltd..

What is the FDA product code for ToxCO?

The FDA product code for ToxCO is CCJ.

Other Devices by Bedfont Scientific, Ltd.

K211918iCOquit® Smokerlyzer® K203695NObreath®

Related Devices (Code: CCJ)

K171408Carbon Monoxide Breath Sensor System (COBSS)Carrot Sense, Inc. K171129CO Check Pro, CO ScreenMD Diagnostics Limited K211918iCOquit® Smokerlyzer®Bedfont 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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