FDA 510(k)

M3290B Patient Information Center iX

N.º K: K183387 · 2019-08-06

Fecha de decisión2019-08-06

Código de productoMHX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

M3290B Patient Information Center iX 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 2019-08-06 under 510(k) number K183387. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the M3290B Patient Information Center iX?

M3290B Patient Information Center iX is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is Philips Medical Systems. The 510(k) number is K183387.

When did M3290B Patient Information Center iX receive FDA 510(k) clearance?

M3290B Patient Information Center iX received FDA 510(k) clearance on 2019-08-06, under 510(k) number K183387.

Who is the listed applicant for M3290B Patient Information Center iX?

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 M3290B Patient Information Center iX?

The FDA product code for M3290B Patient Information Center iX is MHX.

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Otros registros que enlistan a Philips Medical Systems como solicitante

K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System 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 K180017MX40 Release C.01

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Fuente oficial

Ver en la base de datos de la FDA →

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