FDA 510(k)

Vesalius

Número K: K152933 · 2016-03-23

RequerenteTelea Electronic Engineering Srl

Data da decisão2016-03-23

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vesalius is the device name listed in this FDA 510(k) record. The listed applicant is Telea Electronic Engineering Srl. It received FDA 510(k) clearance on 2016-03-23 under 510(k) number K152933. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vesalius?

Vesalius is a medical device that received FDA 510(k) clearance on 2016-03-23. The listed applicant is Telea Electronic Engineering Srl. The 510(k) number is K152933.

When did Vesalius receive FDA 510(k) clearance?

Vesalius received FDA 510(k) clearance on 2016-03-23, under 510(k) number K152933.

Who is the listed applicant for Vesalius?

The FDA 510(k) record lists Telea Electronic Engineering Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vesalius?

The FDA product code for Vesalius is GEI.

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