FDA 510(k)

Electric Breast Pump, model: YM-8166

Número K: K232466 · 2024-01-19

RequerenteGuangdong Youmeng Electrical Technology Co., Ltd.

Data da decisão2024-01-19

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electric Breast Pump, model: YM-8166 is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Youmeng Electrical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K232466. 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: YM-8166?

Electric Breast Pump, model: YM-8166 is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Guangdong Youmeng Electrical Technology Co., Ltd.. The 510(k) number is K232466.

When did Electric Breast Pump, model: YM-8166 receive FDA 510(k) clearance?

Electric Breast Pump, model: YM-8166 received FDA 510(k) clearance on 2024-01-19, under 510(k) number K232466.

Who is the listed applicant for Electric Breast Pump, model: YM-8166?

The FDA 510(k) record lists Guangdong Youmeng Electrical 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, model: YM-8166?

The FDA product code for Electric Breast Pump, model: YM-8166 is HGX.

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Outros registros que listam Guangdong Youmeng Electrical Technology Co., Ltd. como candidato(a)

K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))K252342Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)K252754Wearable Electric Breast Pump (YM-8803)

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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