FDA 510(k)

Electric breast pump (Models: RH-228 and RH-338)

Número K: K201903 · 2021-04-09

RequerenteCixi Ruihong Electric Appliance Co., Ltd.

Data da decisão2021-04-09

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electric breast pump (Models: RH-228 and RH-338) is the device name listed in this FDA 510(k) record. The listed applicant is Cixi Ruihong Electric Appliance Co., Ltd.. It received FDA 510(k) clearance on 2021-04-09 under 510(k) number K201903. 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 (Models: RH-228 and RH-338)?

Electric breast pump (Models: RH-228 and RH-338) is a medical device that received FDA 510(k) clearance on 2021-04-09. The listed applicant is Cixi Ruihong Electric Appliance Co., Ltd.. The 510(k) number is K201903.

When did Electric breast pump (Models: RH-228 and RH-338) receive FDA 510(k) clearance?

Electric breast pump (Models: RH-228 and RH-338) received FDA 510(k) clearance on 2021-04-09, under 510(k) number K201903.

Who is the listed applicant for Electric breast pump (Models: RH-228 and RH-338)?

The FDA 510(k) record lists Cixi Ruihong Electric Appliance Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric breast pump (Models: RH-228 and RH-338)?

The FDA product code for Electric breast pump (Models: RH-228 and RH-338) is HGX.

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Outros registros que listam Cixi Ruihong Electric Appliance Co., Ltd. como candidato(a)

K252744Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)

Dispositivos Relacionados (Código: HGX)

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Fonte oficial

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