FDA 510(k)

일회용 수술 마스크

K-번호: K201924 · 2021-03-15

신청자Qiqihar Hengxin Medical Supplies, Ltd.

결정일2021-03-15

제품 코드FXX

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

결정Substantially Equivalent

기기 요약

Single-Use Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Qiqihar Hengxin Medical Supplies, Ltd.. It received FDA 510(k) clearance on 2021-03-15 under 510(k) number K201924. 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 Single-Use Surgical Mask?

Single-Use Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-03-15. The listed applicant is Qiqihar Hengxin Medical Supplies, Ltd.. The 510(k) number is K201924.

When did Single-Use Surgical Mask receive FDA 510(k) clearance?

Single-Use Surgical Mask received FDA 510(k) clearance on 2021-03-15, under 510(k) number K201924.

Who is the listed applicant for Single-Use Surgical Mask?

The FDA 510(k) record lists Qiqihar Hengxin Medical Supplies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Surgical Mask?

The FDA product code for Single-Use Surgical Mask is FXX.

Qiqihar Hengxin Medical Supplies, Ltd.를 신청인으로 등재한 기타 기록

K201691일회용 수술 마스크(귀 루프 포함)

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