BlueStar and BlueStar Rx
K-Number: K230813 · 2023-07-28
ApplicantWelldoc, Inc.
Decision Date2023-07-28
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
BlueStar and BlueStar Rx is a medical device manufactured by Welldoc, Inc.. It received FDA 510(k) clearance on 2023-07-28 under approval number K230813. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BlueStar and BlueStar Rx?
BlueStar and BlueStar Rx is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by Welldoc, Inc.. The 510(k) number is K230813.
When was BlueStar and BlueStar Rx approved by the FDA?
BlueStar and BlueStar Rx received FDA 510(k) clearance on 2023-07-28, under approval number K230813.
What company makes BlueStar and BlueStar Rx?
BlueStar and BlueStar Rx is manufactured by Welldoc, Inc..
What is the FDA product code for BlueStar and BlueStar Rx?
The FDA product code for BlueStar and BlueStar Rx is NDC.
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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.