510(k) K130294

BRAEMAR CARDIOKEY HOLTER RECORDER by Braemar Manufacturing, LLC — Product Code MWJ

K130294 is an FDA 510(k) premarket notification submitted by Braemar Manufacturing, LLC for the device "BRAEMAR CARDIOKEY HOLTER RECORDER". The FDA issued a decision of Substantially Equivalent on October 16, 2013. The device falls under product code MWJ (Electrocardiograph, Ambulatory (Without Analysis)), a Class II device regulated under 21 CFR 870.2800. Braemar Manufacturing, LLC has at least 2 other 510(k) clearances on record.