TEC-3500 DEFIBRILLATOR

TEC-3500 DEFIBRILLATOR is an FDA 510(k)-cleared medical device (K840258) manufactured by Nihon Kohden America, 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 May 22, 1984. Regulation: 8.