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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices, Breath Trapping, Alcohol
510(k) Number K160613
Device Name Soberlink Cellular Device and Sober Sky Web Portal
Applicant
Soberlink Healthcare, LLC
16787 Beach Blvd. #211
Huntington Beach,  CA  92647
Applicant Contact JENNA COSTA
Correspondent
Obelix Consulting, LLC
12416 Fairfax Ridge Place
Austin,  TX  78738
Correspondent Contact ELISA MALDONADO-HOLMERTZ
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received03/03/2016
Decision Date 07/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02544581
NCT02650180
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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