FDA 510(k)

Yxoss CBR®

N.º K: K192747 · 2020-06-17

Fecha de decisión2020-06-17

Código de productoJEY

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Yxoss CBR® is the device name listed in this FDA 510(k) record. The listed applicant is Reoss GmbH. It received FDA 510(k) clearance on 2020-06-17 under 510(k) number K192747. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Yxoss CBR®?

Yxoss CBR® is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Reoss GmbH. The 510(k) number is K192747.

When did Yxoss CBR® receive FDA 510(k) clearance?

Yxoss CBR® received FDA 510(k) clearance on 2020-06-17, under 510(k) number K192747.

Who is the listed applicant for Yxoss CBR®?

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

What is the FDA product code for Yxoss CBR®?

The FDA product code for Yxoss CBR® is JEY.

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Fuente oficial

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