BlueStar Rx
K-Number: K193654 · 2020-04-07
ApplicantWelldoc, Inc.
Decision Date2020-04-07
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
BlueStar Rx is a medical device manufactured by Welldoc, Inc.. It received FDA 510(k) clearance on 2020-04-07 under approval number K193654. 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 BlueStar Rx?
BlueStar Rx is a medical device that received FDA 510(k) clearance on 2020-04-07. It is manufactured by Welldoc, Inc.. The 510(k) number is K193654.
When was BlueStar Rx approved by the FDA?
BlueStar Rx received FDA 510(k) clearance on 2020-04-07, under approval number K193654.
What company makes BlueStar Rx?
BlueStar Rx is manufactured by Welldoc, Inc..
What is the FDA product code for BlueStar Rx?
The FDA product code for BlueStar Rx is MRZ.
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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.