CARDIOLIFE TEC 7200

CARDIOLIFE TEC 7200 is an FDA 510(k)-cleared medical device (K863405) manufactured by Nihon Kohden America, 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 30, 1986. Regulation: 8.