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FDA 510(k)

joimax 電外科儀器

K 號:K161378 · 2016-11-02

申請人Joimax GmbH
決定日期2016-11-02
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

joimax Electrosurgical Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Joimax GmbH. It received FDA 510(k) clearance on 2016-11-02 under 510(k) number K161378. 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 joimax Electrosurgical Instruments?

joimax Electrosurgical Instruments is a medical device that received FDA 510(k) clearance on 2016-11-02. The listed applicant is Joimax GmbH. The 510(k) number is K161378.

When did joimax Electrosurgical Instruments receive FDA 510(k) clearance?

joimax Electrosurgical Instruments received FDA 510(k) clearance on 2016-11-02, under 510(k) number K161378.

Who is the listed applicant for joimax Electrosurgical Instruments?

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

What is the FDA product code for joimax Electrosurgical Instruments?

The FDA product code for joimax Electrosurgical Instruments is GEI.

相關臨床試驗

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其他以 Joimax GmbH 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。

官方來源

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