510(k) K201633

Terason uSmart 3200T Plus Ultrasound System by Teratech Corporation — Product Code IYN

K201633 is an FDA 510(k) premarket notification submitted by Teratech Corporation for the device "Terason uSmart 3200T Plus Ultrasound System". The FDA issued a decision of Substantially Equivalent on Jul 2, 2020. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Teratech Corporation has 1 other 510(k) clearance on record.