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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 K201206
Device Name Pivot Breath Sensor
Applicant
Carrot, Inc.
1400a Seaport Blvd., Suite 501
Redwood City,  CA  94063
Applicant Contact Sara Lippert
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact Jonathan S. Kahan
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received05/04/2020
Decision Date 06/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT04133064
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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