510(k) K212021

6430 MyLabX75, 6430 MyLab XPro75 by Esaote, S.p.A. — Product Code IYN

K212021 is an FDA 510(k) premarket notification submitted by Esaote, S.p.A. for the device "6430 MyLabX75, 6430 MyLab XPro75". The FDA issued a decision of Substantially Equivalent on September 16, 2021. 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.