FDA 510(k)

RF外科發生器

K 號：K200931 · 2020-11-24

決定日期2020-11-24

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

RF Surgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is Fulwell, LLC. It received FDA 510(k) clearance on 2020-11-24 under 510(k) number K200931. 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 RF Surgical Generator?

RF Surgical Generator is a medical device that received FDA 510(k) clearance on 2020-11-24. The listed applicant is Fulwell, LLC. The 510(k) number is K200931.

When did RF Surgical Generator receive FDA 510(k) clearance?

RF Surgical Generator received FDA 510(k) clearance on 2020-11-24, under 510(k) number K200931.

Who is the listed applicant for RF Surgical Generator?

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

What is the FDA product code for RF Surgical Generator?

The FDA product code for RF Surgical Generator is GEI.

其他以 Fulwell, LLC 為申請人之記錄

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。

K183564電外科發生器

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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