EXTERNAL PACEMAKER ANALYZER MODEL PMA-1

EXTERNAL PACEMAKER ANALYZER MODEL PMA-1 is an FDA 510(k)-cleared medical device (K903966) manufactured by Bio-Tek Instruments, 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 June 18, 1991. Regulation: 8.