PACE 10 NON-INVASIVE EXTERNAL PACEMAKER

PACE 10 NON-INVASIVE EXTERNAL PACEMAKER is an FDA 510(k)-cleared medical device (K871176) manufactured by Medac, 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 22, 1987. Regulation: 8.