BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY

BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY is an FDA 510(k)-cleared medical device (K854919) 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 December 18, 1985. Regulation: 8.