Cleared Traditional

Pivot Breath Sensor

K201206 · Carrot, Inc. · Toxicology

Jun 2021

Decision

422d

Days

Class 2

Risk

About This 510(k) Submission

K201206 is an FDA 510(k) clearance for the Pivot Breath Sensor, a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II — Special Controls, product code CCJ), submitted by Carrot, Inc. (Redwood City, US). The FDA issued a Cleared decision on June 30, 2021, 422 days after receiving the submission on May 4, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number	K201206 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2020
Decision Date	June 30, 2021
Days to Decision	422 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF