FDA 510(k)

Adaptivo

Número K: K152994 · 2016-02-03

RequerenteAurora Technology Development, LLC

Data da decisão2016-02-03

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Adaptivo is the device name listed in this FDA 510(k) record. The listed applicant is Aurora Technology Development, LLC. It received FDA 510(k) clearance on 2016-02-03 under 510(k) number K152994. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Adaptivo?

Adaptivo is a medical device that received FDA 510(k) clearance on 2016-02-03. The listed applicant is Aurora Technology Development, LLC. The 510(k) number is K152994.

When did Adaptivo receive FDA 510(k) clearance?

Adaptivo received FDA 510(k) clearance on 2016-02-03, under 510(k) number K152994.

Who is the listed applicant for Adaptivo?

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

What is the FDA product code for Adaptivo?

The FDA product code for Adaptivo is IYE.

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