510(k) K232336

ES Series V2 by E-Scopics — Product Code IYN

K232336 is an FDA 510(k) premarket notification submitted by E-Scopics for the device "ES Series V2". The FDA issued a decision of Substantially Equivalent on September 26, 2023. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. E-Scopics has at least 3 other 510(k) clearances on record.