MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH

MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH is an FDA 510(k)-cleared medical device (K863153) manufactured by Ocg Technology, 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 January 5, 1987. Regulation: 8.