MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543

MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543 is an FDA 510(k)-cleared medical device (K871915) manufactured by Pace Medical. 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 9, 1987. Regulation: 8.