510(k) K051686

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

K051686 is an FDA 510(k) premarket notification submitted by Getemed Medizin- Und Informationstechnik AG for the device "CARDIOMEM CM 3000-12". The FDA issued a decision of Substantially Equivalent on July 14, 2005. 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.