FDA 510(k)

Pivot Breath Sensor

K-Number: K201206 · 2021-06-30

Decision Date2021-06-30

Product CodeCCJ

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Pivot Breath Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Carrot, Inc.. It received FDA 510(k) clearance on 2021-06-30 under 510(k) number K201206. 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 Pivot Breath Sensor?

Pivot Breath Sensor is a medical device that received FDA 510(k) clearance on 2021-06-30. The listed applicant is Carrot, Inc.. The 510(k) number is K201206.

When did Pivot Breath Sensor receive FDA 510(k) clearance?

Pivot Breath Sensor received FDA 510(k) clearance on 2021-06-30, under 510(k) number K201206.

Who is the listed applicant for Pivot Breath Sensor?

The FDA 510(k) record lists Carrot, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pivot Breath Sensor?

The FDA product code for Pivot Breath Sensor is CCJ.

Related Devices (Code: CCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253119CoSense ETCO MonitorCapnia, Inc.K211918iCOquit® Smokerlyzer®Bedfont Scientific, Ltd.K173238ToxCOBedfont Scientific, Ltd.K171129CO Check Pro, CO ScreenMD Diagnostics Limited K171408Carbon Monoxide Breath Sensor System (COBSS)Carrot Sense, Inc.

Official Source

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