COOK PACEMAKER 216 BIPOLAR CARDIAC -

COOK PACEMAKER 216 BIPOLAR CARDIAC - is an FDA 510(k)-cleared medical device (K841983) 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 July 10, 1984. Regulation: 8.