RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM

RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM is an FDA 510(k)-cleared medical device (K911835) manufactured by Gs Microsystems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 1992. Regulation: 8.