FDA 510(k)

電外科發生器

K 號：K201221 · 2020-09-28

決定日期2020-09-28

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

Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 2020-09-28 under 510(k) number K201221. 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 Electrosurgical Generator?

Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2020-09-28. The listed applicant is New Deantronics Taiwan , Ltd.. The 510(k) number is K201221.

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

Electrosurgical Generator received FDA 510(k) clearance on 2020-09-28, under 510(k) number K201221.

Who is the listed applicant for Electrosurgical Generator?

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

What is the FDA product code for Electrosurgical Generator?

The FDA product code for Electrosurgical Generator is GEI.

其他以 New Deantronics Taiwan , Ltd. 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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