ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND

ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND is an FDA 510(k)-cleared medical device (K901657) 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 September 3, 1990. Regulation: 8.