FDA 510(k)

Electric Breast Pump

Número K: K231595 · 2023-10-26

RequerenteShenzhen Changkun Technology Co., Ltd.

Data da decisão2023-10-26

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electric Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-26 under 510(k) number K231595. 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?

Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2023-10-26. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K231595.

When did Electric Breast Pump receive FDA 510(k) clearance?

Electric Breast Pump received FDA 510(k) clearance on 2023-10-26, under 510(k) number K231595.

Who is the listed applicant for Electric Breast Pump?

The FDA 510(k) record lists Shenzhen Changkun Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Breast Pump?

The FDA product code for Electric Breast Pump is HGX.

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Outros registros que listam Shenzhen Changkun Technology Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: HGX)

K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.

Fonte oficial

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