510(k) K073709

MODIFICATION TO VIEWMATE SYSTEM by Ep Medsystems — Product Code IYN

K073709 is an FDA 510(k) premarket notification submitted by Ep Medsystems for the device "MODIFICATION TO VIEWMATE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 11, 2008. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Ep Medsystems has at least 10 other 510(k) clearances on record.