CARDIODAY, VERSION 2.0

CARDIODAY, VERSION 2.0 is an FDA 510(k)-cleared medical device (K070280) manufactured by Getemed Medizin- Und Informationstechnik AG. 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 22, 2007. Regulation: 8.