FDA 510(k)

碟-FX系統

K 號：K162490 · 2017-01-06

決定日期2017-01-06

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

Disc-FX System is the device name listed in this FDA 510(k) record. The listed applicant is Elliquence, LLC. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K162490. 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 Disc-FX System?

Disc-FX System is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Elliquence, LLC. The 510(k) number is K162490.

When did Disc-FX System receive FDA 510(k) clearance?

Disc-FX System received FDA 510(k) clearance on 2017-01-06, under 510(k) number K162490.

Who is the listed applicant for Disc-FX System?

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 Disc-FX System?

The FDA product code for Disc-FX System is GEI.

其他以 Elliquence, LLC 為申請人之記錄

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