MARK V DUPLEX ULTRASONIC SCAN SYS.

MARK V DUPLEX ULTRASONIC SCAN SYS. is an FDA 510(k)-cleared medical device (K802438) manufactured by Advanced Technology Laboratories, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 20, 1981. Regulation: 8.