FDA 510(k)

富士通視覺結腸內鏡型號 EC-600WL V2

K 號：K160196 · 2016-02-23

決定日期2016-02-23

產品代碼FDF

諮詢委員會GU

決定相當於

器材摘要

Fujifilm Video Colonoscope Model EC-600WL V2 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K160196. 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 Fujifilm Video Colonoscope Model EC-600WL V2?

Fujifilm Video Colonoscope Model EC-600WL V2 is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K160196.

When did Fujifilm Video Colonoscope Model EC-600WL V2 receive FDA 510(k) clearance?

Fujifilm Video Colonoscope Model EC-600WL V2 received FDA 510(k) clearance on 2016-02-23, under 510(k) number K160196.

Who is the listed applicant for Fujifilm Video Colonoscope Model EC-600WL V2?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fujifilm Video Colonoscope Model EC-600WL V2?

The FDA product code for Fujifilm Video Colonoscope Model EC-600WL V2 is FDF.

其他以 Fujifilm Medical Systems U.S.A, Inc. 為申請人之記錄

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相關器械（代碼：FDF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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