FDA 510(k)

INDEX BPM

K-번호: K221486 · 2022-08-30

결정일2022-08-30

제품 코드DXN

자문 위원회CV

결정Substantially Equivalent

기기 요약

INDEX BPM is the device name listed in this FDA 510(k) record. The listed applicant is Ya Horng Electronic Co., Ltd.. It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K221486. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the INDEX BPM?

INDEX BPM is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Ya Horng Electronic Co., Ltd.. The 510(k) number is K221486.

When did INDEX BPM receive FDA 510(k) clearance?

INDEX BPM received FDA 510(k) clearance on 2022-08-30, under 510(k) number K221486.

Who is the listed applicant for INDEX BPM?

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

What is the FDA product code for INDEX BPM?

The FDA product code for INDEX BPM is DXN.

관련 기기 (코드: DXN)

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기기 요약

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관련 임상시험

관련 기기 (코드: DXN)

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