FUKUDA DENSHI MODEL DS-3300 ETR

FUKUDA DENSHI MODEL DS-3300 ETR is an FDA 510(k)-cleared medical device (K897063) 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 31, 1990. Regulation: 8.