510(k) K073147

SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 by Transoma Medical — Product Code MXC

K073147 is an FDA 510(k) premarket notification submitted by Transoma Medical for the device "SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08". The FDA issued a decision of Substantially Equivalent on December 3, 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. Transoma Medical has at least 1 other 510(k) clearance on record.