FDA 510(k)

EPIQ Diagnostic Ultrasound System

N.º K: K200304 · 2020-03-06

Fecha de decisión2020-03-06

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

EPIQ Diagnostic 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 2020-03-06 under 510(k) number K200304. 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 EPIQ Diagnostic Ultrasound System?

EPIQ Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is Philips Ultrasound, Inc.. The 510(k) number is K200304.

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

EPIQ Diagnostic Ultrasound System received FDA 510(k) clearance on 2020-03-06, under 510(k) number K200304.

Who is the listed applicant for EPIQ Diagnostic 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 EPIQ Diagnostic Ultrasound System?

The FDA product code for EPIQ Diagnostic Ultrasound System is IYN.

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Otros registros que enlistan a Philips Ultrasound, Inc. como solicitante

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Dispositivos relacionados (Código: IYN)

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.