510(k) K041163

ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES by Isopure, Corp. — Product Code FIP

K041163 is an FDA 510(k) premarket notification submitted by Isopure, Corp. for the device "ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES". The FDA issued a decision of Substantially Equivalent on October 7, 2004. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Isopure, Corp. has at least 4 other 510(k) clearances on record.