510(k) K042469

BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER by Braemar, Inc. — Product Code MWJ

K042469 is an FDA 510(k) premarket notification submitted by Braemar, Inc. for the device "BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER". The FDA issued a decision of Substantially Equivalent on October 6, 2004. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Braemar, Inc. has at least 9 other 510(k) clearances on record.