FDA 510(k)

X-SURGE

K 號：K171752 · 2017-10-17

決定日期2017-10-17

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

X-SURGE is the device name listed in this FDA 510(k) record. The listed applicant is Genicon, Inc.. It received FDA 510(k) clearance on 2017-10-17 under 510(k) number K171752. 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 X-SURGE?

X-SURGE is a medical device that received FDA 510(k) clearance on 2017-10-17. The listed applicant is Genicon, Inc.. The 510(k) number is K171752.

When did X-SURGE receive FDA 510(k) clearance?

X-SURGE received FDA 510(k) clearance on 2017-10-17, under 510(k) number K171752.

Who is the listed applicant for X-SURGE?

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

What is the FDA product code for X-SURGE?

The FDA product code for X-SURGE is GEI.

其他以 Genicon, Inc. 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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