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FDA 510(k)

Naya Breast Pump System

Número K: K160511 · 2016-06-24

RequerenteNaya Health, Inc.
Data da decisão2016-06-24
Código do produtoHGX
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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