510(k) K131327

BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM by Bio Compression Systems, Inc. — Product Code JOW

K131327 is an FDA 510(k) premarket notification submitted by Bio Compression Systems, Inc. for the device "BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on July 18, 2013. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Bio Compression Systems, Inc. has at least 10 other 510(k) clearances on record.