FDA 510(k)

DyeVert NG Contrast Modulation System

Número K: K161505 · 2016-08-03

Data da decisão2016-08-03

Código do produtoDXT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

DyeVert NG 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 2016-08-03 under 510(k) number K161505. 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 NG Contrast Modulation System?

DyeVert NG Contrast Modulation System is a medical device that received FDA 510(k) clearance on 2016-08-03. The listed applicant is Osprey Medical, Inc.. The 510(k) number is K161505.

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

DyeVert NG Contrast Modulation System received FDA 510(k) clearance on 2016-08-03, under 510(k) number K161505.

Who is the listed applicant for DyeVert NG 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 NG Contrast Modulation System?

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

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Fonte oficial

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