FDA 510(k)

invendoscopy E200 系統

K 號：K161355 · 2016-08-25

決定日期2016-08-25

產品代碼FDF

諮詢委員會GU

決定相當於

器材摘要

invendoscopy E200 System is the device name listed in this FDA 510(k) record. The listed applicant is Invendo Medical GmbH. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K161355. 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 invendoscopy E200 System?

invendoscopy E200 System is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is Invendo Medical GmbH. The 510(k) number is K161355.

When did invendoscopy E200 System receive FDA 510(k) clearance?

invendoscopy E200 System received FDA 510(k) clearance on 2016-08-25, under 510(k) number K161355.

Who is the listed applicant for invendoscopy E200 System?

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

What is the FDA product code for invendoscopy E200 System?

The FDA product code for invendoscopy E200 System is FDF.

其他以 Invendo Medical GmbH 為申請人之記錄

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相關器械（代碼：FDF）

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官方來源

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