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FDA 510(k)

Carbon Monoxide Breath Sensor System (COBSS)

K-Number: K171408 · 2017-09-29

ApplicantCarrot Sense, Inc.
Decision Date2017-09-29
Product CodeCCJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Carbon Monoxide Breath Sensor System (COBSS) is a medical device manufactured by Carrot Sense, Inc.. It received FDA 510(k) clearance on 2017-09-29 under approval number K171408. The device is classified under product code CCJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Carbon Monoxide Breath Sensor System (COBSS)?

Carbon Monoxide Breath Sensor System (COBSS) is a medical device that received FDA 510(k) clearance on 2017-09-29. It is manufactured by Carrot Sense, Inc.. The 510(k) number is K171408.

When was Carbon Monoxide Breath Sensor System (COBSS) approved by the FDA?

Carbon Monoxide Breath Sensor System (COBSS) received FDA 510(k) clearance on 2017-09-29, under approval number K171408.

What company makes Carbon Monoxide Breath Sensor System (COBSS)?

Carbon Monoxide Breath Sensor System (COBSS) is manufactured by Carrot Sense, Inc..

What is the FDA product code for Carbon Monoxide Breath Sensor System (COBSS)?

The FDA product code for Carbon Monoxide Breath Sensor System (COBSS) is CCJ.

Related Clinical Trials

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Related PubMed Literature

PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Related Devices (Code: CCJ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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