MODEL 325C UNIPOLAR CARDIAC PULSE GEN.

MODEL 325C UNIPOLAR CARDIAC PULSE GEN. is an FDA 510(k)-cleared medical device (K812832) manufactured by Cook Pacemaker Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on November 4, 1981. Regulation: 8.