MARK 500 ULTRASOUOND SYSTEM

MARK 500 ULTRASOUOND SYSTEM is an FDA 510(k)-cleared medical device (K820364) 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 March 25, 1982. Regulation: 8.