FDA 510(k)

Epix 電外科探針配煙霧抽離功能

K 號：K151480 · 2016-02-19

決定日期2016-02-19

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

Epix Electrosurgical Probe with Smoke Evacuation is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K151480. 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 Epix Electrosurgical Probe with Smoke Evacuation?

Epix Electrosurgical Probe with Smoke Evacuation is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Applied Medical Resources. The 510(k) number is K151480.

When did Epix Electrosurgical Probe with Smoke Evacuation receive FDA 510(k) clearance?

Epix Electrosurgical Probe with Smoke Evacuation received FDA 510(k) clearance on 2016-02-19, under 510(k) number K151480.

Who is the listed applicant for Epix Electrosurgical Probe with Smoke Evacuation?

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

What is the FDA product code for Epix Electrosurgical Probe with Smoke Evacuation?

The FDA product code for Epix Electrosurgical Probe with Smoke Evacuation is GEI.

其他以 Applied Medical Resources 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。

K200021Applied Medical 鏡頭 K162676Voyant開放融合裝置 K153017Voyant精緻融合 K153288Voyant開放融合裝置

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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