FDA 510(k)

Lumify Ultrasound System

N.º K: K162549 · 2016-10-03

Fecha de decisión2016-10-03

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Lumify Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Health Care. It received FDA 510(k) clearance on 2016-10-03 under 510(k) number K162549. 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 Lumify Ultrasound System?

Lumify Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-10-03. The listed applicant is Philips Health Care. The 510(k) number is K162549.

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

Lumify Ultrasound System received FDA 510(k) clearance on 2016-10-03, under 510(k) number K162549.

Who is the listed applicant for Lumify Ultrasound System?

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

What is the FDA product code for Lumify Ultrasound System?

The FDA product code for Lumify Ultrasound System is IYN.

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Otros registros que enlistan a Philips Health Care como solicitante

K2013523D Auto LAA K200974QLAB Advanced Quantification Software K200179Collaboration Live K191647QLAB Advanced Quantification Software K192226Lumify Diagnostic Ultrasound System K190913QLAB Advanced Quantification Software 13

Ver todos los 11 dispositivos →

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.