FUKUDA DENSHI EH-11

FUKUDA DENSHI EH-11 is an FDA 510(k)-cleared medical device (K834059) 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 June 20, 1985. Regulation: 8.