FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR

FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR is an FDA 510(k)-cleared medical device (K971131) 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 October 2, 1997. Regulation: 8.