ARRHYTHMIA SYSTEM AC-11

ARRHYTHMIA SYSTEM AC-11 is an FDA 510(k)-cleared medical device (K841084) manufactured by Fukuda Denshi USA, 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 January 31, 1985. Regulation: 8.