FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES

FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES is an FDA 510(k)-cleared medical device (K850897) 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 April 9, 1985. Regulation: 8.