FDA 510(k)

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)

K-번호: K193449 · 2020-09-11

신청자Guangdong Horigen Mother & Baby Products Co., Ltd.

결정일2020-09-11

제품 코드HGX

자문 위원회OB

결정Substantially Equivalent

기기 요약

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) 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 2020-09-11 under 510(k) number K193449. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)?

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. The 510(k) number is K193449.

When did Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) receive FDA 510(k) clearance?

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) received FDA 510(k) clearance on 2020-09-11, under 510(k) number K193449.

Who is the listed applicant for Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)?

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 Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)?

The FDA product code for Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) is HGX.

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

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