Carbon Monoxide Breath Sensor System (COBSS)

Analyzer, Gas, Carbon-monoxide, Gaseous-phase

Carrot Sense, Inc.

The following data is part of a premarket notification filed by Carrot Sense, Inc. with the FDA for Carbon Monoxide Breath Sensor System (cobss).

Pre-market Notification Details

• Device ID: K171408
• 510k Number: K171408
• Device Name: Carbon Monoxide Breath Sensor System (COBSS)
• Classification: Analyzer, Gas, Carbon-monoxide, Gaseous-phase
• Applicant: Carrot Sense, Inc. 1600 Seaport Blvd, Suite 150 Redwood City, CA 94063
• Contact: Daniel J. Balbierz
• Correspondent: Jonathan S. Kahan; Hogan Lovells US LLP 555 Thirteenth Street NW Washington, DC 20004
• Product Code: CCJ
• CFR Regulation Number: 868.1430 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-05-12
• Decision Date: 2017-09-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08635710003014	K171408	000
08635710003007	K171408	000
00863571000318	K171408	000
00863571000301	K171408	000