FDA 510(k)

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)

N.º K: K193449 · 2020-09-11

SolicitanteGuangdong Horigen Mother & Baby Products Co., Ltd.

Fecha de decisión2020-09-11

Código de productoHGX

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) 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 2020-09-11 under 510(k) number K193449. 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 (model KP033_01), Electric Double Breast Pump (model KP053_01)?

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. The 510(k) number is K193449.

When did Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) receive FDA 510(k) clearance?

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) received FDA 510(k) clearance on 2020-09-11, under 510(k) number K193449.

Who is the listed applicant for Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)?

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 (model KP033_01), Electric Double Breast Pump (model KP053_01)?

The FDA product code for Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) 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)K212564Electric Breast Pump K201152Electric Breast Pump K201974Single-use medical face mask 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.