FDA 510(k)

Aerin 医療筆

K 號：K161994 · 2016-09-22

決定日期2016-09-22

產品代碼GEI

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

Aerin Medical Stylus is the device name listed in this FDA 510(k) record. The listed applicant is Aerin Medical, Inc.. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K161994. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aerin Medical Stylus?

Aerin Medical Stylus is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Aerin Medical, Inc.. The 510(k) number is K161994.

When did Aerin Medical Stylus receive FDA 510(k) clearance?

Aerin Medical Stylus received FDA 510(k) clearance on 2016-09-22, under 510(k) number K161994.

Who is the listed applicant for Aerin Medical Stylus?

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

What is the FDA product code for Aerin Medical Stylus?

The FDA product code for Aerin Medical Stylus is GEI.

其他以 Aerin Medical, Inc. 為申請人之記錄

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相關器械（代碼：GEI）

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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