510(k) K905294

EUB-315 by Hitachi Medical Corp. of America — Product Code IYO

K905294 is an FDA 510(k) premarket notification submitted by Hitachi Medical Corp. of America for the device "EUB-315". The FDA issued a decision of Substantially Equivalent on February 25, 1991. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Hitachi Medical Corp. of America has at least 10 other 510(k) clearances on record.