510(k) K063035

SLEUTH IMPLANTABLE ECG MONITORING SYSTEM by Transnoma Medical, Inc. — Product Code MXC

K063035 is an FDA 510(k) premarket notification submitted by Transnoma Medical, Inc. for the device "SLEUTH IMPLANTABLE ECG MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 1, 2007. The device falls under product code MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)), a Class II device regulated under 21 CFR 870.2800.