510(k) K912819

SC1150 CW/PD by Pie Medical Equipment B.V. — Product Code IYN

K912819 is an FDA 510(k) premarket notification submitted by Pie Medical Equipment B.V. for the device "SC1150 CW/PD". The FDA issued a decision of Substantially Equivalent on January 9, 1992. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Pie Medical Equipment B.V. has at least 7 other 510(k) clearances on record.