510(k) K212851

EchoSK and EchoSGyn modules for EchoS Family devices by Echolight S.P.A — Product Code IYO

K212851 is an FDA 510(k) premarket notification submitted by Echolight S.P.A for the device "EchoSK and EchoSGyn modules for EchoS Family devices". The FDA issued a decision of Substantially Equivalent on March 16, 2022. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Echolight S.P.A has at least 2 other 510(k) clearances on record.