510(k) K071733

DL900 SERIES HOLTER RECORDER by Braemar, Inc. — Product Code MWJ

K071733 is an FDA 510(k) premarket notification submitted by Braemar, Inc. for the device "DL900 SERIES HOLTER RECORDER". The FDA issued a decision of Substantially Equivalent on July 24, 2007. 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.