FDA 510(k)

TACVAC

K 號：K153459 · 2016-01-28

決定日期2016-01-28

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

TACVAC is the device name listed in this FDA 510(k) record. The listed applicant is Athena Gtx. It received FDA 510(k) clearance on 2016-01-28 under 510(k) number K153459. 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 TACVAC?

TACVAC is a medical device that received FDA 510(k) clearance on 2016-01-28. The listed applicant is Athena Gtx. The 510(k) number is K153459.

When did TACVAC receive FDA 510(k) clearance?

TACVAC received FDA 510(k) clearance on 2016-01-28, under 510(k) number K153459.

Who is the listed applicant for TACVAC?

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

What is the FDA product code for TACVAC?

The FDA product code for TACVAC is BTA.

其他以 Athena Gtx 為申請人之記錄

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相關器械（代碼：BTA）

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