FDA 510(k)

Single-use medical face mask

K-번호: K201974 · 2021-03-07

신청자Guangdong Horigen Mother & Baby Products Co., Ltd.

결정일2021-03-07

제품 코드FXX

자문 위원회SU

결정Substantially Equivalent

기기 요약

Single-use medical face mask is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. It received FDA 510(k) clearance on 2021-03-07 under 510(k) number K201974. 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 medical face mask?

Single-use medical face mask is a medical device that received FDA 510(k) clearance on 2021-03-07. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. The 510(k) number is K201974.

When did Single-use medical face mask receive FDA 510(k) clearance?

Single-use medical face mask received FDA 510(k) clearance on 2021-03-07, under 510(k) number K201974.

Who is the listed applicant for Single-use medical face mask?

The FDA 510(k) record lists Guangdong Horigen Mother & Baby Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use medical face mask?

The FDA product code for Single-use medical face mask is FXX.

Guangdong Horigen Mother & Baby Products Co., Ltd.를 신청인으로 등재한 기타 기록

K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)K212564Electric Breast Pump K201152Electric Breast Pump K193449Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)K182413Electric Breast Pump K162747Proture Double Electric Breast Pump

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