FDA 510(k)

NTU-USB Ultrasound USB Box

N.º K: K173486 · 2018-07-11

Fecha de decisión2018-07-11

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

NTU-USB Ultrasound USB Box is the device name listed in this FDA 510(k) record. The listed applicant is National Taiwan University. It received FDA 510(k) clearance on 2018-07-11 under 510(k) number K173486. 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 NTU-USB Ultrasound USB Box?

NTU-USB Ultrasound USB Box is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is National Taiwan University. The 510(k) number is K173486.

When did NTU-USB Ultrasound USB Box receive FDA 510(k) clearance?

NTU-USB Ultrasound USB Box received FDA 510(k) clearance on 2018-07-11, under 510(k) number K173486.

Who is the listed applicant for NTU-USB Ultrasound USB Box?

The FDA 510(k) record lists National Taiwan University as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NTU-USB Ultrasound USB Box?

The FDA product code for NTU-USB Ultrasound USB Box is IYN.

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Dispositivos relacionados (Código: IYN)

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