FDA 510(k)

HiCardi+ H100

K-번호: K232670 · 2024-09-20

결정일2024-09-20

제품 코드DSH

자문 위원회CV

결정Substantially Equivalent

기기 요약

HiCardi+ H100 is the device name listed in this FDA 510(k) record. The listed applicant is MEZOO Co., Ltd.. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K232670. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the HiCardi+ H100?

HiCardi+ H100 is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is MEZOO Co., Ltd.. The 510(k) number is K232670.

When did HiCardi+ H100 receive FDA 510(k) clearance?

HiCardi+ H100 received FDA 510(k) clearance on 2024-09-20, under 510(k) number K232670.

Who is the listed applicant for HiCardi+ H100?

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

What is the FDA product code for HiCardi+ H100?

The FDA product code for HiCardi+ H100 is DSH.

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HiCardi+ H100

기기 요약

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관련 임상시험

관련 기기 (코드: DSH)

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