DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER

DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER is an FDA 510(k)-cleared medical device (K903437) manufactured by Keller Medical Specialties Products, 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 November 15, 1990. Regulation: 8.