FDA 510(k)

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

N.º K: K250207 · 2025-08-11

Fecha de decisión2025-08-11

Código de productoHGX

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Anker Innovations Limited como solicitante

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.

Fuente oficial

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