510(k) K091206

SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL by Transoma Medical — Product Code MXC

K091206 is an FDA 510(k) premarket notification submitted by Transoma Medical for the device "SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL". The FDA issued a decision of Substantially Equivalent on May 18, 2009. 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.