K162225

Substantially Equivalent

WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System

Applicant: Welldoc, Inc.
Product code: MRZ
Advisory panel: General Hospital
Date received: 2016-08-08
Decision date: 2016-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.