FDA 510(k)

Anzai Respiratory Gating System

K-Number: K160432 · 2016-04-22

Decision Date2016-04-22

Product CodeLHN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Anzai Respiratory Gating System is a medical device manufactured by Anzai Medical Co., Ltd.. It received FDA 510(k) clearance on 2016-04-22 under approval number K160432. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anzai Respiratory Gating System?

Anzai Respiratory Gating System is a medical device that received FDA 510(k) clearance on 2016-04-22. It is manufactured by Anzai Medical Co., Ltd.. The 510(k) number is K160432.

When was Anzai Respiratory Gating System approved by the FDA?

Anzai Respiratory Gating System received FDA 510(k) clearance on 2016-04-22, under approval number K160432.

What company makes Anzai Respiratory Gating System?

Anzai Respiratory Gating System is manufactured by Anzai Medical Co., Ltd..

What is the FDA product code for Anzai Respiratory Gating System?

The FDA product code for Anzai Respiratory Gating System is LHN.

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Other Devices by Anzai Medical Co., Ltd.

K170719Anzai Respiratory Gating System

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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.