FDA 510(k)

足下垂系統（型號XFT-2001D）

K 號：K162718 · 2017-11-30

決定日期2017-11-30

產品代碼GZI

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Foot Drop System (Model XFT-2001D) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Xft Medical Limited. It received FDA 510(k) clearance on 2017-11-30 under 510(k) number K162718. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Foot Drop System (Model XFT-2001D)?

Foot Drop System (Model XFT-2001D) is a medical device that received FDA 510(k) clearance on 2017-11-30. The listed applicant is Shenzhen Xft Medical Limited. The 510(k) number is K162718.

When did Foot Drop System (Model XFT-2001D) receive FDA 510(k) clearance?

Foot Drop System (Model XFT-2001D) received FDA 510(k) clearance on 2017-11-30, under 510(k) number K162718.

Who is the listed applicant for Foot Drop System (Model XFT-2001D)?

The FDA 510(k) record lists Shenzhen Xft Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Foot Drop System (Model XFT-2001D)?

The FDA product code for Foot Drop System (Model XFT-2001D) is GZI.

其他以 Shenzhen Xft Medical Limited 為申請人之記錄

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