BlueStar CGM insulin dose calculator
K-Number: K222888 · 2023-08-11
ApplicantWelldoc, Inc.
Decision Date2023-08-11
Product CodeQRX
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
BlueStar CGM insulin dose calculator is a medical device manufactured by Welldoc, Inc.. It received FDA 510(k) clearance on 2023-08-11 under approval number K222888. The device is classified under product code QRX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BlueStar CGM insulin dose calculator?
BlueStar CGM insulin dose calculator is a medical device that received FDA 510(k) clearance on 2023-08-11. It is manufactured by Welldoc, Inc.. The 510(k) number is K222888.
When was BlueStar CGM insulin dose calculator approved by the FDA?
BlueStar CGM insulin dose calculator received FDA 510(k) clearance on 2023-08-11, under approval number K222888.
What company makes BlueStar CGM insulin dose calculator?
BlueStar CGM insulin dose calculator is manufactured by Welldoc, Inc..
What is the FDA product code for BlueStar CGM insulin dose calculator?
The FDA product code for BlueStar CGM insulin dose calculator is QRX.
Related Clinical Trials
Other Devices by Welldoc, Inc.
Related Devices (Code: QRX)
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.