FDA 510(k)

ULYSS Multi View Sinuscope

Número K: K153701 · 2016-09-09

Data da decisão2016-09-09

Código do produtoEOB

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

ULYSS Multi View Sinuscope is the device name listed in this FDA 510(k) record. The listed applicant is Sopro-Comeg GmbH. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K153701. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ULYSS Multi View Sinuscope?

ULYSS Multi View Sinuscope is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Sopro-Comeg GmbH. The 510(k) number is K153701.

When did ULYSS Multi View Sinuscope receive FDA 510(k) clearance?

ULYSS Multi View Sinuscope received FDA 510(k) clearance on 2016-09-09, under 510(k) number K153701.

Who is the listed applicant for ULYSS Multi View Sinuscope?

The FDA 510(k) record lists Sopro-Comeg GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULYSS Multi View Sinuscope?

The FDA product code for ULYSS Multi View Sinuscope is EOB.

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