FDA 510(k)

純視系統

K 號：K173392 · 2017-12-12

決定日期2017-12-12

產品代碼FDF

諮詢委員會GU

決定相當於

器材摘要

Pure-Vu System is the device name listed in this FDA 510(k) record. The listed applicant is Motus GI Medical Technologies , Ltd.. It received FDA 510(k) clearance on 2017-12-12 under 510(k) number K173392. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pure-Vu System?

Pure-Vu System is a medical device that received FDA 510(k) clearance on 2017-12-12. The listed applicant is Motus GI Medical Technologies , Ltd.. The 510(k) number is K173392.

When did Pure-Vu System receive FDA 510(k) clearance?

Pure-Vu System received FDA 510(k) clearance on 2017-12-12, under 510(k) number K173392.

Who is the listed applicant for Pure-Vu System?

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

What is the FDA product code for Pure-Vu System?

The FDA product code for Pure-Vu System is FDF.

其他以 Motus GI Medical Technologies , Ltd. 為申請人之記錄

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