FDA 510(k)

CareEvent inclusive of the CareEvent Mobile Application accessory

N.º K: K161164 · 2016-06-24

Fecha de decisión2016-06-24

Código de productoMSX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

CareEvent inclusive of the CareEvent Mobile Application accessory 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 2016-06-24 under 510(k) number K161164. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CareEvent inclusive of the CareEvent Mobile Application accessory?

CareEvent inclusive of the CareEvent Mobile Application accessory is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Philips Medical Systems. The 510(k) number is K161164.

When did CareEvent inclusive of the CareEvent Mobile Application accessory receive FDA 510(k) clearance?

CareEvent inclusive of the CareEvent Mobile Application accessory received FDA 510(k) clearance on 2016-06-24, under 510(k) number K161164.

Who is the listed applicant for CareEvent inclusive of the CareEvent Mobile Application accessory?

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 CareEvent inclusive of the CareEvent Mobile Application accessory?

The FDA product code for CareEvent inclusive of the CareEvent Mobile Application accessory is MSX.

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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 K183387M3290B Patient Information Center iX

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Fuente oficial

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