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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Welldoc, Inc.. It received FDA 510(k) clearance on 2023-07-28 under 510(k) 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. The listed applicant is Welldoc, Inc.. The 510(k) number is K230813.

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

BlueStar and BlueStar Rx received FDA 510(k) clearance on 2023-07-28, under 510(k) number K230813.

Who is the listed applicant for BlueStar and 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 and BlueStar Rx?

The FDA product code for BlueStar and 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.

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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.

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