DYNASCOPE MONITOR DS-800

DYNASCOPE MONITOR DS-800 is an FDA 510(k)-cleared medical device (K844348) 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 December 3, 1984. Regulation: 8.