FDA 510(k)

ImaCor Zura 隨身式 ZHH-010

K 號：K220490 · 2022-04-08

決定日期2022-04-08

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：IYN）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：IYN）

官方來源