FUKUDA DENSHI MODEL FX-3101

FUKUDA DENSHI MODEL FX-3101 is an FDA 510(k)-cleared medical device (K901817) 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 August 22, 1990. Regulation: 8.