UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR

UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR is an FDA 510(k)-cleared medical device (K770197) manufactured by Cardiac Pacemakers, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on February 6, 1977. Regulation: 8.