FDA 510(k)

Enivo™

K 號：K223373 · 2023-04-07

決定日期2023-04-07

產品代碼BTA

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Enivo™ is the device name listed in this FDA 510(k) record. The listed applicant is Aroa Biosurgery , Ltd.. It received FDA 510(k) clearance on 2023-04-07 under 510(k) number K223373. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Enivo™?

Enivo™ is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Aroa Biosurgery , Ltd.. The 510(k) number is K223373.

When did Enivo™ receive FDA 510(k) clearance?

Enivo™ received FDA 510(k) clearance on 2023-04-07, under 510(k) number K223373.

Who is the listed applicant for Enivo™?

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

What is the FDA product code for Enivo™?

The FDA product code for Enivo™ is BTA.

其他以 Aroa Biosurgery , Ltd. 為申請人之記錄

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相關器械（代碼：BTA）

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