510(k) K160613— Soberlink Cellular Device and Sober Sky Web Portal

Substantially Equivalent

Soberlink Healthcare, LLC

Clearance details

Applicant: Soberlink Healthcare, LLC
Product code: Code DJZ
Advisory panel: Clinical Toxicology
Date received: 2016-03-03
Decision date: 2016-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington Beach, CA, US

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