FUKUDA DENSHI MODEL FCP-231

FUKUDA DENSHI MODEL FCP-231 is an FDA 510(k)-cleared medical device (K874768) 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 December 17, 1987. Regulation: 8.