UNIFOCAL 1 UNIPOLAR DEMAND R WAVE

UNIFOCAL 1 UNIPOLAR DEMAND R WAVE is an FDA 510(k)-cleared medical device (K791955) manufactured by American Pacemaker Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on November 26, 1979. Regulation: 8.