FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR

FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR is an FDA 510(k)-cleared medical device (K134046) 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 February 11, 2015. Regulation: 8.