ELECTRODE/PACER SYSTEM ANALYZER PMA 400

ELECTRODE/PACER SYSTEM ANALYZER PMA 400 is an FDA 510(k)-cleared medical device (K810604) manufactured by Telectronics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 13, 1981. Regulation: 8.