FDA 510(k)

BR-FHUS 导航 1.0

K号: K171309 · 2017-09-29

决定日期2017-09-29

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

BR-FHUS Navigation 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Taihao Medical, Inc.. It received FDA 510(k) clearance on 2017-09-29 under 510(k) number K171309. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BR-FHUS Navigation 1.0?

BR-FHUS Navigation 1.0 is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Taihao Medical, Inc.. The 510(k) number is K171309.

When did BR-FHUS Navigation 1.0 receive FDA 510(k) clearance?

BR-FHUS Navigation 1.0 received FDA 510(k) clearance on 2017-09-29, under 510(k) number K171309.

Who is the listed applicant for BR-FHUS Navigation 1.0?

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

What is the FDA product code for BR-FHUS Navigation 1.0?

The FDA product code for BR-FHUS Navigation 1.0 is IYO.

列明Taihao Medical, 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。

K210670BU-CAD K171709BR-FHUS 观察器 1.0 K151075BR-ABVS 观察器 1.0

官方来源

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