FDA 510(k)

ImaCor Zura Handheld ZHH-010

K-Number: K220490 · 2022-04-08

Decision Date2022-04-08

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ImaCor Zura Handheld ZHH-010 is a medical device manufactured by Imacor, Inc.. It received FDA 510(k) clearance on 2022-04-08 under approval number K220490. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImaCor Zura Handheld ZHH-010?

ImaCor Zura Handheld ZHH-010 is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by Imacor, Inc.. The 510(k) number is K220490.

When was ImaCor Zura Handheld ZHH-010 approved by the FDA?

ImaCor Zura Handheld ZHH-010 received FDA 510(k) clearance on 2022-04-08, under approval number K220490.

What company makes ImaCor Zura Handheld ZHH-010?

ImaCor Zura Handheld ZHH-010 is manufactured by Imacor, Inc..

What is the FDA product code for ImaCor Zura Handheld ZHH-010?

The FDA product code for ImaCor Zura Handheld ZHH-010 is IYN.

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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.