FUKUDA DENSHI MODEL LX-3100

FUKUDA DENSHI MODEL LX-3100 is an FDA 510(k)-cleared medical device (K903514) 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 January 29, 1991. Regulation: 8.