FDA 510(k)

Bluemoon

K号: K242386 · 2025-05-05

决定日期2025-05-05

产品代码EBZ

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决定实质等同

器械摘要

Bluemoon is the device name listed in this FDA 510(k) record. The listed applicant is Genoss Co., Ltd.. It received FDA 510(k) clearance on 2025-05-05 under 510(k) number K242386. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Bluemoon?

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

When did Bluemoon receive FDA 510(k) clearance?

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

Who is the listed applicant for Bluemoon?

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

What is the FDA product code for Bluemoon?

The FDA product code for Bluemoon is EBZ.

列明Genoss Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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