510(k) K102507

AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR by Tz Medical, Inc. — Product Code DSI

K102507 is an FDA 510(k) premarket notification submitted by Tz Medical, Inc. for the device "AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR". The FDA issued a decision of Substantially Equivalent on June 13, 2011. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Tz Medical, Inc. has at least 10 other 510(k) clearances on record.