BIPOLAR CARDIAC PACEMAKER, MODEL 110

BIPOLAR CARDIAC PACEMAKER, MODEL 110 is an FDA 510(k)-cleared medical device (K861009) manufactured by Cardiac Control Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on April 22, 1986. Regulation: 8.