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FDA 510(k)

HealthChek Network Health Station

Número K: K152107 · 2016-04-12

RequerenteHealthchek Network, LLC
Data da decisão2016-04-12
Código do produtoDXN
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

HealthChek Network Health Station is the device name listed in this FDA 510(k) record. The listed applicant is Healthchek Network, LLC. It received FDA 510(k) clearance on 2016-04-12 under 510(k) number K152107. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HealthChek Network Health Station?

HealthChek Network Health Station is a medical device that received FDA 510(k) clearance on 2016-04-12. The listed applicant is Healthchek Network, LLC. The 510(k) number is K152107.

When did HealthChek Network Health Station receive FDA 510(k) clearance?

HealthChek Network Health Station received FDA 510(k) clearance on 2016-04-12, under 510(k) number K152107.

Who is the listed applicant for HealthChek Network Health Station?

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

What is the FDA product code for HealthChek Network Health Station?

The FDA product code for HealthChek Network Health Station is DXN.

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Fonte oficial

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