510(k) K030856

ER800 SERIES ECG EVENT RECORDER by Braemar Corp. — Product Code MWJ

K030856 is an FDA 510(k) premarket notification submitted by Braemar Corp. for the device "ER800 SERIES ECG EVENT RECORDER". The FDA issued a decision of Substantially Equivalent on March 28, 2003. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Braemar Corp. has at least 9 other 510(k) clearances on record.