FDA 510(k)

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System

Número K: K212704 · 2021-09-24

Data da decisão2021-09-24

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti 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 2021-09-24 under 510(k) number K212704. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System?

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-09-24. The listed applicant is Philips Medical Systems. The 510(k) number is K212704.

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

Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System received FDA 510(k) clearance on 2021-09-24, under 510(k) number K212704.

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

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

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Outros registros que listam Philips Medical Systems como candidato(a)

K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series 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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Fonte oficial

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