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 IDK171408
510k NumberK171408
Device Name:Carbon Monoxide Breath Sensor System (COBSS)
ClassificationAnalyzer, Gas, Carbon-monoxide, Gaseous-phase
Applicant Carrot Sense, Inc. 1600 Seaport Blvd, Suite 150 Redwood City,  CA  94063
ContactDaniel J. Balbierz
CorrespondentJonathan S. Kahan
Hogan Lovells US LLP 555 Thirteenth Street NW Washington,  DC  20004
Product CodeCCJ  
CFR Regulation Number868.1430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-12
Decision Date2017-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08635710003014 K171408 000
08635710003007 K171408 000
00863571000318 K171408 000
00863571000301 K171408 000

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