510(k) K954220

EUB-8000 by Hitachi Medical Corp. of America — Product Code IYN

K954220 is an FDA 510(k) premarket notification submitted by Hitachi Medical Corp. of America for the device "EUB-8000". The FDA issued a decision of Substantially Equivalent on May 7, 1997. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Hitachi Medical Corp. of America has at least 10 other 510(k) clearances on record.