FDA 510(k)

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)

Número K: K250207 · 2025-08-11

Data da decisão2025-08-11

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) is the device name listed in this FDA 510(k) record. The listed applicant is Anker Innovations Limited. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K250207. 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 eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)?

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is Anker Innovations Limited. The 510(k) number is K250207.

When did eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) receive FDA 510(k) clearance?

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) received FDA 510(k) clearance on 2025-08-11, under 510(k) number K250207.

Who is the listed applicant for eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)?

The FDA 510(k) record lists Anker Innovations Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)?

The FDA product code for eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) is HGX.

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Outros registros que listam Anker Innovations Limited como candidato(a)

K254300eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)

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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