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FDA 510(k)

Naya Breast Pump System

N.º K: K160511 · 2016-06-24

SolicitanteNaya Health, Inc.
Fecha de decisión2016-06-24
Código de productoHGX
Comité asesorOB
DecisiónSubstantially Equivalent

Resumen del dispositivo

Naya Breast Pump System is the device name listed in this FDA 510(k) record. The listed applicant is Naya Health, Inc.. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K160511. 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 Naya Breast Pump System?

Naya Breast Pump System is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Naya Health, Inc.. The 510(k) number is K160511.

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

Naya Breast Pump System received FDA 510(k) clearance on 2016-06-24, under 510(k) number K160511.

Who is the listed applicant for Naya Breast Pump System?

The FDA 510(k) record lists Naya Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Naya Breast Pump System?

The FDA product code for Naya Breast Pump System is HGX.

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Dispositivos relacionados (Código: HGX)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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.

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