Carbon Monoxide Breath Sensor System (COBSS)— 510(k) K171408

Name: FDA 510(k) clearance K171408
Creator: U.S. Food and Drug Administration
Published: 2017-09-29

Substantially Equivalent

Carrot Sense, Inc.

FDA 510(k) clearance K171408 for Carbon Monoxide Breath Sensor System (COBSS), Substantially Equivalent on 2017-09-29. Applicant: Carrot Sense, Inc.. Device class: 2.

Clearance details

Applicant: Carrot Sense, Inc.
Product code: Code CCJ
Device class: Class 2
Regulation: 21 CFR 868.1430
Advisory panel: Anesthesiology
Date received: 2017-05-12
Decision date: 2017-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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