510(k) K221140

P20 Elite Series Digital Color Doppler Ultrasound System by Sonoscape Medical Corp. — Product Code IYN

K221140 is an FDA 510(k) premarket notification submitted by Sonoscape Medical Corp. for the device "P20 Elite Series Digital Color Doppler Ultrasound System". The FDA issued a decision of Substantially Equivalent on September 13, 2022. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Sonoscape Medical Corp. has at least 10 other 510(k) clearances on record.