510(k) K110285

NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER by Nephros, Inc. — Product Code FIP

K110285 is an FDA 510(k) premarket notification submitted by Nephros, Inc. for the device "NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER". The FDA issued a decision of Substantially Equivalent on July 14, 2011. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Nephros, Inc. has at least 8 other 510(k) clearances on record.