FDA 510(k)

Visaris Vision® (Vision C, Vision U. Vision V, Vision X)

Número K: K160620 · 2016-03-30

Data da decisão2016-03-30

Código do produtoKPR

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Visaris Vision® (Vision C, Vision U. Vision V, Vision X) is the device name listed in this FDA 510(k) record. The listed applicant is Visaris D.O.O. Belgrade. It received FDA 510(k) clearance on 2016-03-30 under 510(k) number K160620. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Visaris Vision® (Vision C, Vision U. Vision V, Vision X)?

Visaris Vision® (Vision C, Vision U. Vision V, Vision X) is a medical device that received FDA 510(k) clearance on 2016-03-30. The listed applicant is Visaris D.O.O. Belgrade. The 510(k) number is K160620.

When did Visaris Vision® (Vision C, Vision U. Vision V, Vision X) receive FDA 510(k) clearance?

Visaris Vision® (Vision C, Vision U. Vision V, Vision X) received FDA 510(k) clearance on 2016-03-30, under 510(k) number K160620.

Who is the listed applicant for Visaris Vision® (Vision C, Vision U. Vision V, Vision X)?

The FDA 510(k) record lists Visaris D.O.O. Belgrade as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Visaris Vision® (Vision C, Vision U. Vision V, Vision X)?

The FDA product code for Visaris Vision® (Vision C, Vision U. Vision V, Vision X) is KPR.

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