FDA 510(k)

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10

Número K: K163688 · 2017-02-23

Data da decisão2017-02-23

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 is the device name listed in this FDA 510(k) record. The listed applicant is Medisono, LLC. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K163688. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10?

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Medisono, LLC. The 510(k) number is K163688.

When did Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 receive FDA 510(k) clearance?

Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 received FDA 510(k) clearance on 2017-02-23, under 510(k) number K163688.

Who is the listed applicant for Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10?

The FDA 510(k) record lists Medisono, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10?

The FDA product code for Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 is IYN.

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