FDA 510(k)

gi-4000 電外科電流發生器

K 號：K172805 · 2017-10-23

決定日期2017-10-23

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

gi-4000 Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2017-10-23 under 510(k) number K172805. 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 gi-4000 Electrosurgical Generator?

gi-4000 Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K172805.

When did gi-4000 Electrosurgical Generator receive FDA 510(k) clearance?

gi-4000 Electrosurgical Generator received FDA 510(k) clearance on 2017-10-23, under 510(k) number K172805.

Who is the listed applicant for gi-4000 Electrosurgical Generator?

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

What is the FDA product code for gi-4000 Electrosurgical Generator?

The FDA product code for gi-4000 Electrosurgical Generator is GEI.

其他以 United States Endoscopy Group, 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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官方來源

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