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FDA 510(k)

BlueStar Rx

K-Number: K203434 · 2021-09-08

ApplicantWelldoc, Inc.
Decision Date2021-09-08
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BlueStar Rx is a medical device manufactured by Welldoc, Inc.. It received FDA 510(k) clearance on 2021-09-08 under approval number K203434. 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 Rx?

BlueStar Rx is a medical device that received FDA 510(k) clearance on 2021-09-08. It is manufactured by Welldoc, Inc.. The 510(k) number is K203434.

When was BlueStar Rx approved by the FDA?

BlueStar Rx received FDA 510(k) clearance on 2021-09-08, under approval number K203434.

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 NDC.

Other Devices by Welldoc, Inc.

K162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System K162532WellDoc BlueStar, WellDoc BlueStar Rx K190013WellDoc BlueStar K193654BlueStar Rx K222888BlueStar CGM insulin dose calculator K230813BlueStar and BlueStar Rx

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Related Devices (Code: NDC)

K160949Go Dose SystemEli Lilly and Company K161433Insulia Diabetes Management CompanionVoluntis Sa. K172177Insulia Diabetes Management CompanionVoluntis Sa. K163664Health-e-Connect System with IDAAlr Technologies K152300GlucommanderGlytec, LLC K170669Insulia Diabetes Management CompanionVoluntis Sa.

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.

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