WellDoc BlueStar
K-Number: K190013 · 2019-11-04
ApplicantWelldoc, Inc.
Decision Date2019-11-04
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
WellDoc BlueStar is a medical device manufactured by Welldoc, Inc.. It received FDA 510(k) clearance on 2019-11-04 under approval number K190013. 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 is a medical device that received FDA 510(k) clearance on 2019-11-04. It is manufactured by Welldoc, Inc.. The 510(k) number is K190013.
When was WellDoc BlueStar approved by the FDA?
WellDoc BlueStar received FDA 510(k) clearance on 2019-11-04, under approval number K190013.
What company makes WellDoc BlueStar?
WellDoc BlueStar is manufactured by Welldoc, Inc..
What is the FDA product code for WellDoc BlueStar?
The FDA product code for WellDoc BlueStar is MRZ.
Other Devices by Welldoc, Inc.
Related Devices (Code: MRZ)
K160492Hospira Sapphire SetsHospira, Inc.
K162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemWelldoc, Inc.
K171346Sapphire SetsIcu Medical
K162532WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc.
K173531Lockbox for Perfusor Space PCA Infusion PumpB.Braun Medical, 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.