FDA 510(k)

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

Número K: K193449 · 2020-09-11

RequerenteGuangdong Horigen Mother & Baby Products Co., Ltd.

Data da decisão2020-09-11

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Guangdong Horigen Mother & Baby Products Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: HGX)

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Fonte oficial

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