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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 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.

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. 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.

Other records listing Taihao Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210670BU-CADK171709BR-FHUS Viewer 1.0K151075BR-ABVS Viewer 1.0

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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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