KING OF HEARTS EXPRESS (E.X.) MONITOR

KING OF HEARTS EXPRESS (E.X.) MONITOR is an FDA 510(k)-cleared medical device (K920984) manufactured by Instromedix, 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 13, 1992. Regulation: 8.