PACEMAKER SYS. ANALYZER 378

PACEMAKER SYS. ANALYZER 378 is an FDA 510(k)-cleared medical device (K832959) 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 November 13, 1983. Regulation: 8.