FDA 510(k)

Monarch Platform, Urology

K-Number: K213334 · 2022-04-29

Decision Date2022-04-29

Product CodeFGB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Monarch Platform, Urology is a medical device manufactured by Auris Health, Inc.. It received FDA 510(k) clearance on 2022-04-29 under approval number K213334. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Monarch Platform, Urology?

Monarch Platform, Urology is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Auris Health, Inc.. The 510(k) number is K213334.

When was Monarch Platform, Urology approved by the FDA?

Monarch Platform, Urology received FDA 510(k) clearance on 2022-04-29, under approval number K213334.

What company makes Monarch Platform, Urology?

Monarch Platform, Urology is manufactured by Auris Health, Inc..

What is the FDA product code for Monarch Platform, Urology?

The FDA product code for Monarch Platform, Urology is FGB.

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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.