FUKUDA DENSHI CARDIMAX FK-12

FUKUDA DENSHI CARDIMAX FK-12 is an FDA 510(k)-cleared medical device (K813022) manufactured by Brentwood Instruments, 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 December 1, 1981. Regulation: 8.