CARDIOMEM CM 3000-12BT

CARDIOMEM CM 3000-12BT is an FDA 510(k)-cleared medical device (K063042) 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 May 29, 2007. Regulation: 8.