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 the device name listed in this FDA 510(k) record. The listed applicant is Imacor, Inc.. It received FDA 510(k) clearance on 2022-04-08 under 510(k) 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. The listed applicant is Imacor, Inc.. The 510(k) number is K220490.

When did ImaCor Zura Handheld ZHH-010 receive FDA 510(k) clearance?

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

Who is the listed applicant for ImaCor Zura Handheld ZHH-010?

The FDA 510(k) record lists Imacor, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: IYN)

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.

Official Source

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