PORTABLE DEFIBRILLATOR/MONITOR ED 425

PORTABLE DEFIBRILLATOR/MONITOR ED 425 is an FDA 510(k)-cleared medical device (K851092) manufactured by Honeywell, 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 9, 1985. Regulation: 8.