FDA 510(k)

AdTec

K 號：K160393 · 2016-05-26

決定日期2016-05-26

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

AdTec is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2016-05-26 under 510(k) number K160393. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AdTec?

AdTec is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is Aesculap, Inc.. The 510(k) number is K160393.

When did AdTec receive FDA 510(k) clearance?

AdTec received FDA 510(k) clearance on 2016-05-26, under 510(k) number K160393.

Who is the listed applicant for AdTec?

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

What is the FDA product code for AdTec?

The FDA product code for AdTec is GCJ.

其他以 Aesculap, Inc. 為申請人之記錄

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相關器械（代碼：GCJ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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