FDA 510(k)

RS80A Diagnostic Ultrasound System

N.º K: K162094 · 2016-08-26

Fecha de decisión2016-08-26

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

RS80A Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K162094. 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 RS80A Diagnostic Ultrasound System?

RS80A Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Samsung Medison Co., Ltd.. The 510(k) number is K162094.

When did RS80A Diagnostic Ultrasound System receive FDA 510(k) clearance?

RS80A Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-08-26, under 510(k) number K162094.

Who is the listed applicant for RS80A Diagnostic Ultrasound System?

The FDA 510(k) record lists Samsung Medison Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RS80A Diagnostic Ultrasound System?

The FDA product code for RS80A Diagnostic Ultrasound System is IYN.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.