MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS is an FDA 510(k)-cleared medical device (K013564) manufactured by Cambridge Heart, 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 20, 2001. Regulation: 8.