FDA 510(k)

Surgi Max 超級

K 號：K170107 · 2017-05-03

決定日期2017-05-03

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

Surgi Max Ultra is the device name listed in this FDA 510(k) record. The listed applicant is Elliquence, LLC. It received FDA 510(k) clearance on 2017-05-03 under 510(k) number K170107. 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 Surgi Max Ultra?

Surgi Max Ultra is a medical device that received FDA 510(k) clearance on 2017-05-03. The listed applicant is Elliquence, LLC. The 510(k) number is K170107.

When did Surgi Max Ultra receive FDA 510(k) clearance?

Surgi Max Ultra received FDA 510(k) clearance on 2017-05-03, under 510(k) number K170107.

Who is the listed applicant for Surgi Max Ultra?

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

What is the FDA product code for Surgi Max Ultra?

The FDA product code for Surgi Max Ultra is GEI.

其他以 Elliquence, LLC 為申請人之記錄

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