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FDA 510(k)

波威Bantam/PRO電外科電流發生器，波威DERM 941電外科電流發生器，波威DERM 942電外科電流發生器

K 號：K161134 · 2016-06-20

申請人Bovie Medical Corporation
決定日期2016-06-20
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

Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical Corporation. It received FDA 510(k) clearance on 2016-06-20 under 510(k) number K161134. 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 Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator?

Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2016-06-20. The listed applicant is Bovie Medical Corporation. The 510(k) number is K161134.

When did Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator receive FDA 510(k) clearance?

Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator received FDA 510(k) clearance on 2016-06-20, under 510(k) number K161134.

Who is the listed applicant for Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator?

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

What is the FDA product code for Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator?

The FDA product code for Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator is GEI.

相關臨床試驗

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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其他以 Bovie Medical Corporation 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。

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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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