510(k) K070280

CARDIODAY, VERSION 2.0 by Getemed Medizin- Und Informationstechnik AG — Product Code DQK

K070280 is an FDA 510(k) premarket notification submitted by Getemed Medizin- Und Informationstechnik AG for the device "CARDIODAY, VERSION 2.0". The FDA issued a decision of Substantially Equivalent on February 23, 2007. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Getemed Medizin- Und Informationstechnik AG has at least 7 other 510(k) clearances on record.