FDA 510(k)

哈比伯 EUS RFA

K 號：K161305 · 2016-07-07

決定日期2016-07-07

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

Habib EUS RFA is the device name listed in this FDA 510(k) record. The listed applicant is Emcision , Ltd.. It received FDA 510(k) clearance on 2016-07-07 under 510(k) number K161305. 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 Habib EUS RFA?

Habib EUS RFA is a medical device that received FDA 510(k) clearance on 2016-07-07. The listed applicant is Emcision , Ltd.. The 510(k) number is K161305.

When did Habib EUS RFA receive FDA 510(k) clearance?

Habib EUS RFA received FDA 510(k) clearance on 2016-07-07, under 510(k) number K161305.

Who is the listed applicant for Habib EUS RFA?

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

What is the FDA product code for Habib EUS RFA?

The FDA product code for Habib EUS RFA is GEI.

其他以 Emcision , Ltd. 為申請人之記錄

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K180165哈比伯內分泌HPB

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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