510(k) K031066

VIEWMATE ULTRASOUND IMAGING SYSTEM by Ep Medsystems — Product Code IYN

K031066 is an FDA 510(k) premarket notification submitted by Ep Medsystems for the device "VIEWMATE ULTRASOUND IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 17, 2003. 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.