MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER

MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER is an FDA 510(k)-cleared medical device (K905403) 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 October 15, 1991. Regulation: 8.