EUB-305 DIAGNOSTIC ULTRASOUND DEVICE

EUB-305 DIAGNOSTIC ULTRASOUND DEVICE is an FDA 510(k)-cleared medical device (K870878) manufactured by Hitachi Medical Corp. of America. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 21, 1988. Regulation: 8.