FDA 510(k)

Xperius Ultrasound System

N.º K: K182529 · 2018-10-23

Fecha de decisión2018-10-23

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Xperius Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, Inc.. It received FDA 510(k) clearance on 2018-10-23 under 510(k) number K182529. 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 Xperius Ultrasound System?

Xperius Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-10-23. The listed applicant is Philips Ultrasound, Inc.. The 510(k) number is K182529.

When did Xperius Ultrasound System receive FDA 510(k) clearance?

Xperius Ultrasound System received FDA 510(k) clearance on 2018-10-23, under 510(k) number K182529.

Who is the listed applicant for Xperius Ultrasound System?

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

What is the FDA product code for Xperius Ultrasound System?

The FDA product code for Xperius Ultrasound System is IYN.

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Fuente oficial

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