FDA 510(k)

SonicEye Dual-Array Ultrasound System

Número K: K192253 · 2020-02-25

Data da decisão2020-02-25

Código do produtoIYO

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

SonicEye Dual-Array Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Sonivate Medical, Inc.. It received FDA 510(k) clearance on 2020-02-25 under 510(k) number K192253. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SonicEye Dual-Array Ultrasound System?

SonicEye Dual-Array Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-02-25. The listed applicant is Sonivate Medical, Inc.. The 510(k) number is K192253.

When did SonicEye Dual-Array Ultrasound System receive FDA 510(k) clearance?

SonicEye Dual-Array Ultrasound System received FDA 510(k) clearance on 2020-02-25, under 510(k) number K192253.

Who is the listed applicant for SonicEye Dual-Array Ultrasound System?

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

What is the FDA product code for SonicEye Dual-Array Ultrasound System?

The FDA product code for SonicEye Dual-Array Ultrasound System is IYO.

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