Cleared Traditional

Carbon Monoxide Breath Sensor System (COBSS)

K171408 · Carrot Sense, Inc. · Toxicology

Sep 2017

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K171408 is an FDA 510(k) clearance for the Carbon Monoxide Breath Sensor System (COBSS), a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II — Special Controls, product code CCJ), submitted by Carrot Sense, Inc. (Redwood City, US). The FDA issued a Cleared decision on September 29, 2017, 140 days after receiving the submission on May 12, 2017. This device falls under the Toxicology review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number	K171408 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2017
Decision Date	September 29, 2017
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF