FDA 510(k)

D-Care 수술용 3층 마스크, D-Care 의료용 3층 마스크

K-번호: K213970 · 2022-01-23

신청자Danameco Medical Joint Stock Corporation

결정일2022-01-23

제품 코드FXX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정Substantially Equivalent

기기 요약

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply is the device name listed in this FDA 510(k) record. The listed applicant is Danameco Medical Joint Stock Corporation. It received FDA 510(k) clearance on 2022-01-23 under 510(k) number K213970. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply?

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply is a medical device that received FDA 510(k) clearance on 2022-01-23. The listed applicant is Danameco Medical Joint Stock Corporation. The 510(k) number is K213970.

When did D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply receive FDA 510(k) clearance?

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply received FDA 510(k) clearance on 2022-01-23, under 510(k) number K213970.

Who is the listed applicant for D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply?

The FDA 510(k) record lists Danameco Medical Joint Stock Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply?

The FDA product code for D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply is FXX.

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FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

D-Care 수술용 3층 마스크, D-Care 의료용 3층 마스크

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FXX)

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