510(k) K133149

BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM by Mar Cor Purification, Inc. — Product Code FIP

K133149 is an FDA 510(k) premarket notification submitted by Mar Cor Purification, Inc. for the device "BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 30, 2014. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Mar Cor Purification, Inc. has at least 3 other 510(k) clearances on record.