SUSI II PACEMAKER SURVEILLANCE MONITOR

SUSI II PACEMAKER SURVEILLANCE MONITOR is an FDA 510(k)-cleared medical device (K792602) manufactured by Ela Medical, 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 March 24, 1980. Regulation: 8.