FDA 510(k)

MagiCath II

K-번호: K210929 · 2022-09-13

결정일2022-09-13

제품 코드FOZ

자문 위원회HO

결정Substantially Equivalent

기기 요약

MagiCath II is the device name listed in this FDA 510(k) record. The listed applicant is Woo Young Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-09-13 under 510(k) number K210929. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the MagiCath II?

MagiCath II is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Woo Young Medical Co., Ltd.. The 510(k) number is K210929.

When did MagiCath II receive FDA 510(k) clearance?

MagiCath II received FDA 510(k) clearance on 2022-09-13, under 510(k) number K210929.

Who is the listed applicant for MagiCath II?

The FDA 510(k) record lists Woo Young Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MagiCath II?

The FDA product code for MagiCath II is FOZ.

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MagiCath II

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FOZ)

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