THE CRITERION II PACING SYS. MONITOR

THE CRITERION II PACING SYS. MONITOR is an FDA 510(k)-cleared medical device (K802782) manufactured by Dart Medical Equipment. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 1980. Regulation: 8.