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FDA 510(k)

Pivot Breath Sensor

K-Number: K201206 · 2021-06-30

ApplicantCarrot, Inc.
Decision Date2021-06-30
Product CodeCCJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Pivot Breath Sensor is a medical device manufactured by Carrot, Inc.. It received FDA 510(k) clearance on 2021-06-30 under approval 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. It is manufactured by Carrot, Inc.. The 510(k) number is K201206.

When was Pivot Breath Sensor approved by the FDA?

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

What company makes Pivot Breath Sensor?

Pivot Breath Sensor is manufactured by Carrot, Inc..

What is the FDA product code for Pivot Breath Sensor?

The FDA product code for Pivot Breath Sensor is CCJ.

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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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