FDA 510(k)

Fiagon 导航系统

K号: K163209 · 2017-09-14

决定日期2017-09-14

产品代码HAW

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决定实质等同

器械摘要

Fiagon Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Fiagon GmbH. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K163209. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fiagon Navigation System?

Fiagon Navigation System is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is Fiagon GmbH. The 510(k) number is K163209.

When did Fiagon Navigation System receive FDA 510(k) clearance?

Fiagon Navigation System received FDA 510(k) clearance on 2017-09-14, under 510(k) number K163209.

Who is the listed applicant for Fiagon Navigation System?

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

What is the FDA product code for Fiagon Navigation System?

The FDA product code for Fiagon Navigation System is HAW.

列明Fiagon GmbH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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