CARDIMAX MODEL FX-2111

CARDIMAX MODEL FX-2111 is an FDA 510(k)-cleared medical device (K955416) manufactured by Fukuda Denshi USA, 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 July 14, 1996. Regulation: 8.