EUB-515 DIAGNOSTIC ULTRASOUND DEVICE

EUB-515 DIAGNOSTIC ULTRASOUND DEVICE is an FDA 510(k)-cleared medical device (K897042) manufactured by Hitachi Medical Corp. of America. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 12, 1990. Regulation: 8.