FDA 510(k)

Voluson E10

N.º K: K201768 · 2020-10-22

Fecha de decisión2020-10-22

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Voluson E10 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2020-10-22 under 510(k) number K201768. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Voluson E10?

Voluson E10 is a medical device that received FDA 510(k) clearance on 2020-10-22. The listed applicant is GE Healthcare. The 510(k) number is K201768.

When did Voluson E10 receive FDA 510(k) clearance?

Voluson E10 received FDA 510(k) clearance on 2020-10-22, under 510(k) number K201768.

Who is the listed applicant for Voluson E10?

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

What is the FDA product code for Voluson E10?

The FDA product code for Voluson E10 is IYN.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.