FDA 510(k)

DyeVert Contrast Modulation System

Número K: K153141 · 2016-02-04

Data da decisão2016-02-04

Código do produtoDXT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

DyeVert Contrast Modulation System is the device name listed in this FDA 510(k) record. The listed applicant is Osprey Medical, Inc.. It received FDA 510(k) clearance on 2016-02-04 under 510(k) number K153141. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DyeVert Contrast Modulation System?

DyeVert Contrast Modulation System is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Osprey Medical, Inc.. The 510(k) number is K153141.

When did DyeVert Contrast Modulation System receive FDA 510(k) clearance?

DyeVert Contrast Modulation System received FDA 510(k) clearance on 2016-02-04, under 510(k) number K153141.

Who is the listed applicant for DyeVert Contrast Modulation System?

The FDA 510(k) record lists Osprey Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DyeVert Contrast Modulation System?

The FDA product code for DyeVert Contrast Modulation System is DXT.

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Fonte oficial

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