ARCOLITH 2100-CARDIAC PULSE GENERATOR

ARCOLITH 2100-CARDIAC PULSE GENERATOR is an FDA 510(k)-cleared medical device (K792216) manufactured by Arco Medical Products Co.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on November 28, 1979. Regulation: 8.