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FDA 510(k)

Bluemoon

K-Number: K242386 · 2025-05-05

ApplicantGenoss Co., Ltd.
Decision Date2025-05-05
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bluemoon is a medical device manufactured by Genoss Co., Ltd.. It received FDA 510(k) clearance on 2025-05-05 under approval number K242386. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bluemoon?

Bluemoon is a medical device that received FDA 510(k) clearance on 2025-05-05. It is manufactured by Genoss Co., Ltd.. The 510(k) number is K242386.

When was Bluemoon approved by the FDA?

Bluemoon received FDA 510(k) clearance on 2025-05-05, under approval number K242386.

What company makes Bluemoon?

Bluemoon is manufactured by Genoss Co., Ltd..

What is the FDA product code for Bluemoon?

The FDA product code for Bluemoon is EBZ.

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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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