CARDIOSCAN - TM BEING APPLIED FOR

CARDIOSCAN - TM BEING APPLIED FOR is an FDA 510(k)-cleared medical device (K841263) manufactured by Interspec, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 1984. Regulation: 8.