510(k) K081444

BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM by Braemar, Inc. — Product Code DSI

K081444 is an FDA 510(k) premarket notification submitted by Braemar, Inc. for the device "BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 31, 2008. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Braemar, Inc. has at least 9 other 510(k) clearances on record.