PACEMAKER PATIENT MGMT. SYSTEM

PACEMAKER PATIENT MGMT. SYSTEM is an FDA 510(k)-cleared medical device (K801810) manufactured by Siemens Elema AB. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 4, 1981. Regulation: 8.