FDA 510(k)

純淨視系統

K 號：K191220 · 2019-06-06

決定日期2019-06-06

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 2019-06-06 under 510(k) number K191220. 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 2019-06-06. The listed applicant is Motus GI Medical Technologies , Ltd.. The 510(k) number is K191220.

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

Pure Vu System received FDA 510(k) clearance on 2019-06-06, under 510(k) number K191220.

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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