510(k) K032926

EKG SPEAKS by Medtronic Vascular — Product Code KRE

K032926 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "EKG SPEAKS". The FDA issued a decision of Substantially Equivalent on October 15, 2003. The device falls under product code KRE (Analyzer, Pacemaker Generator Function, Indirect), a Class II device regulated under 21 CFR 870.3640. Medtronic Vascular has at least 10 other 510(k) clearances on record.