510(k) K072008

BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER by Braemar, Inc. — Product Code DRG

K072008 is an FDA 510(k) premarket notification submitted by Braemar, Inc. for the device "BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER". The FDA issued a decision of Substantially Equivalent on October 3, 2007. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Braemar, Inc. has at least 9 other 510(k) clearances on record.