510(k) K063042

CARDIOMEM CM 3000-12BT by Getemed Medizin- Und Informationstechnik AG — Product Code MWJ

K063042 is an FDA 510(k) premarket notification submitted by Getemed Medizin- Und Informationstechnik AG for the device "CARDIOMEM CM 3000-12BT". The FDA issued a decision of Substantially Equivalent on May 30, 2007. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Getemed Medizin- Und Informationstechnik AG has at least 7 other 510(k) clearances on record.