Pivot Breath Sensor— 510(k) K201206

Substantially Equivalent

Carrot, Inc.

FDA 510(k) clearance K201206 for Pivot Breath Sensor, Substantially Equivalent on 2021-06-30. Applicant: Carrot, Inc.. Device class: 2.

Clearance details

Applicant: Carrot, Inc.
Product code: Code CCJ
Device class: Class 2
Regulation: 21 CFR 868.1430
Advisory panel: Anesthesiology
Date received: 2020-05-04
Decision date: 2021-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.