FDA 510(k)

伊士康麥格迪恩電外科電源發生器，雙極腳踏開關

K 號：K193145 · 2020-03-24

決定日期2020-03-24

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

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch is the device name listed in this FDA 510(k) record. The listed applicant is Megadyne Medical Products, Inc.. It received FDA 510(k) clearance on 2020-03-24 under 510(k) number K193145. 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 Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch?

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch is a medical device that received FDA 510(k) clearance on 2020-03-24. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K193145.

When did Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch receive FDA 510(k) clearance?

Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch received FDA 510(k) clearance on 2020-03-24, under 510(k) number K193145.

Who is the listed applicant for Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch?

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

What is the FDA product code for Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch?

The FDA product code for Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch is GEI.

其他以 Megadyne Medical Products, Inc. 為申請人之記錄

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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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