FDA 510(k)

Electric Breast Pump

N.º K: K212564 · 2022-05-06

SolicitanteGuangdong Horigen Mother & Baby Products Co., Ltd.

Fecha de decisión2022-05-06

Código de productoHGX

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Electric Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K212564. 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 Electric Breast Pump?

Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. The 510(k) number is K212564.

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

Electric Breast Pump received FDA 510(k) clearance on 2022-05-06, under 510(k) number K212564.

Who is the listed applicant for Electric Breast Pump?

The FDA 510(k) record lists Guangdong Horigen Mother & Baby Products 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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Otros registros que enlistan a Guangdong Horigen Mother & Baby Products Co., Ltd. como solicitante

K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)K201152Electric Breast Pump K201974Single-use medical face mask K193449Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)K182413Electric Breast Pump K162747Proture Double Electric Breast Pump

Ver todos los 7 dispositivos →

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

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.