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FDA 510(k)

BR-FHUS Navigation 1.0

K-Number: K171309 · 2017-09-29

ApplicantTaihao Medical, Inc.
Decision Date2017-09-29
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Taihao Medical, Inc.. The 510(k) number is K171309.

When was BR-FHUS Navigation 1.0 approved by the FDA?

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

What company makes BR-FHUS Navigation 1.0?

BR-FHUS Navigation 1.0 is manufactured by Taihao Medical, Inc..

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

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

Other Devices by Taihao Medical, Inc.

K151075BR-ABVS Viewer 1.0 K171709BR-FHUS Viewer 1.0 K210670BU-CAD

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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