SIEMENS-ELEMA PULSE GENERATOR 678

SIEMENS-ELEMA PULSE GENERATOR 678 is an FDA 510(k)-cleared medical device (K802864) manufactured by Siemens Elema AB. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on February 4, 1981. Regulation: 8.