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FDA 510(k)

BR-ABVS Viewer 1.0

K-Number: K151075 · 2016-01-15

ApplicantTaihao Medical, Inc.
Decision Date2016-01-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BR-ABVS Viewer 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 2016-01-15 under 510(k) number K151075. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BR-ABVS Viewer 1.0?

BR-ABVS Viewer 1.0 is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Taihao Medical, Inc.. The 510(k) number is K151075.

When did BR-ABVS Viewer 1.0 receive FDA 510(k) clearance?

BR-ABVS Viewer 1.0 received FDA 510(k) clearance on 2016-01-15, under 510(k) number K151075.

Who is the listed applicant for BR-ABVS Viewer 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-ABVS Viewer 1.0?

The FDA product code for BR-ABVS Viewer 1.0 is LLZ.

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 1.0K171309BR-FHUS Navigation 1.0

Related Devices (Code: LLZ)

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.

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Official Source

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

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