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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 the device name listed in this FDA 510(k) record. The listed applicant is Welldoc, Inc.. It received FDA 510(k) clearance on 2021-09-08 under 510(k) 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. The listed applicant is Welldoc, Inc.. The 510(k) number is K203434.

When did BlueStar Rx receive FDA 510(k) clearance?

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

Who is the listed applicant for BlueStar Rx?

The FDA 510(k) record lists Welldoc, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BlueStar Rx?

The FDA product code for BlueStar Rx is NDC.

Other records listing Welldoc, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NDC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254102GlucommanderGlytec, LLCK260910EndoTool IV Cloud 1.0Glooko, Inc.K253512MiniMed Go AppMedtronic MinimedK253281UpDocUpdoc, Inc.K252104T1D1Comerge AGK241088EndoTool IV (3.1)Monarch Medical Technologies

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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