FDA 510(k)

Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley

N.º K: K170078 · 2017-05-17

Fecha de decisión2017-05-17

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley is the device name listed in this FDA 510(k) record. The listed applicant is Medisono, LLC. It received FDA 510(k) clearance on 2017-05-17 under 510(k) number K170078. 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 Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley?

Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley is a medical device that received FDA 510(k) clearance on 2017-05-17. The listed applicant is Medisono, LLC. The 510(k) number is K170078.

When did Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley receive FDA 510(k) clearance?

Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley received FDA 510(k) clearance on 2017-05-17, under 510(k) number K170078.

Who is the listed applicant for Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley?

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 Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley?

The FDA product code for Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley is IYN.

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