FUKUDA DENSHI MODEL FCP-15

FUKUDA DENSHI MODEL FCP-15 is an FDA 510(k)-cleared medical device (K871025) 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 March 23, 1987. Regulation: 8.