WellDoc BlueStar, WellDoc BlueStar Rx
K-Number: K162532 · 2017-01-12
ApplicantWelldoc, Inc.
Decision Date2017-01-12
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
WellDoc BlueStar, WellDoc BlueStar Rx is a medical device manufactured by Welldoc, Inc.. It received FDA 510(k) clearance on 2017-01-12 under approval number K162532. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the WellDoc BlueStar, WellDoc BlueStar Rx?
WellDoc BlueStar, WellDoc BlueStar Rx is a medical device that received FDA 510(k) clearance on 2017-01-12. It is manufactured by Welldoc, Inc.. The 510(k) number is K162532.
When was WellDoc BlueStar, WellDoc BlueStar Rx approved by the FDA?
WellDoc BlueStar, WellDoc BlueStar Rx received FDA 510(k) clearance on 2017-01-12, under approval number K162532.
What company makes WellDoc BlueStar, WellDoc BlueStar Rx?
WellDoc BlueStar, WellDoc BlueStar Rx is manufactured by Welldoc, Inc..
What is the FDA product code for WellDoc BlueStar, WellDoc BlueStar Rx?
The FDA product code for WellDoc BlueStar, WellDoc BlueStar Rx is MRZ.
Other Devices by Welldoc, Inc.
Related Devices (Code: MRZ)
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K162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemWelldoc, Inc.
K171346Sapphire SetsIcu Medical
K173531Lockbox for Perfusor Space PCA Infusion PumpB.Braun Medical, Inc.
K190013WellDoc BlueStarWelldoc, Inc.
K193654BlueStar RxWelldoc, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.