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FDA 510(k)

The Pump by Babyation

N.º K: K173699 · 2018-04-04

SolicitanteBabyation, LLC
Fecha de decisión2018-04-04
Código de productoHGX
Comité asesorOB
DecisiónSubstantially Equivalent

Resumen del dispositivo

The Pump by Babyation is the device name listed in this FDA 510(k) record. The listed applicant is Babyation, LLC. It received FDA 510(k) clearance on 2018-04-04 under 510(k) number K173699. 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 The Pump by Babyation?

The Pump by Babyation is a medical device that received FDA 510(k) clearance on 2018-04-04. The listed applicant is Babyation, LLC. The 510(k) number is K173699.

When did The Pump by Babyation receive FDA 510(k) clearance?

The Pump by Babyation received FDA 510(k) clearance on 2018-04-04, under 510(k) number K173699.

Who is the listed applicant for The Pump by Babyation?

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

What is the FDA product code for The Pump by Babyation?

The FDA product code for The Pump by Babyation 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.

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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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