FDA 510(k)

富士视频结肠镜型号EC-600WL V2

K号: K160196 · 2016-02-23

决定日期2016-02-23

产品代码FDF

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Fujifilm Medical Systems U.S.A, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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