510(k) K183191

6420 Ultrasound System by Esaote, S.p.A. — Product Code IYN

K183191 is an FDA 510(k) premarket notification submitted by Esaote, S.p.A. for the device "6420 Ultrasound System". The FDA issued a decision of Substantially Equivalent on December 4, 2018. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Esaote, S.p.A. has at least 10 other 510(k) clearances on record.