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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name analyzer, gas, carbon-monoxide, gaseous-phase
510(k) Number K171408
Device Name Carbon Monoxide Breath Sensor System (COBSS)
Applicant
Carrot Sense, Inc.
1600 Seaport Blvd, Suite 150
redwood city,  CA  94063
Applicant Contact daniel j. balbierz
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
washington,  DC  20004
Correspondent Contact jonathan s. kahan
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received05/12/2017
Decision Date 09/29/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT03148613
Reviewed by Third Party No
Combination Product No
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