FDA 510(k)

富士胶片外科手术系统

K号: K162836 · 2017-03-13

申请人Fujifilm New Development U.S.A., Inc.

决定日期2017-03-13

产品代码GCJ

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 Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm New Development U.S.A., Inc.. It received FDA 510(k) clearance on 2017-03-13 under 510(k) number K162836. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FUJIFILM Surgical System?

FUJIFILM Surgical System is a medical device that received FDA 510(k) clearance on 2017-03-13. The listed applicant is Fujifilm New Development U.S.A., Inc.. The 510(k) number is K162836.

When did FUJIFILM Surgical System receive FDA 510(k) clearance?

FUJIFILM Surgical System received FDA 510(k) clearance on 2017-03-13, under 510(k) number K162836.

Who is the listed applicant for FUJIFILM Surgical System?

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

What is the FDA product code for FUJIFILM Surgical System?

The FDA product code for FUJIFILM Surgical System is GCJ.

列明Fujifilm New Development 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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相关器械（代码：GCJ）

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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