FDA 510(k)

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

N.º K: K211597 · 2021-09-08

Fecha de decisión2021-09-08

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2021-09-08 under 510(k) number K211597. 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 Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System?

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-09-08. The listed applicant is Philips Medical Systems. The 510(k) number is K211597.

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

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System received FDA 510(k) clearance on 2021-09-08, under 510(k) number K211597.

Who is the listed applicant for EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System?

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

What is the FDA product code for EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System?

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

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Otros registros que enlistan a Philips Medical Systems como solicitante

K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System K210560Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph K191738PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph K192875Philips Biosensor BX100 K183387M3290B Patient Information Center iX K180017MX40 Release C.01

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Dispositivos relacionados (Código: IYN)

Fuente oficial

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