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FDA 510(k)

The Pump by Babyation

Número K: K173699 · 2018-04-04

RequerenteBabyation, LLC
Data da decisão2018-04-04
Código do produtoHGX
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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)

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