SCM-400 HOLTER SYSTEM

SCM-400 HOLTER SYSTEM is an FDA 510(k)-cleared medical device (K860950) 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 May 1, 1986. Regulation: 8.