510(k) K021560

MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS by Ameriwater — Product Code FIP

K021560 is an FDA 510(k) premarket notification submitted by Ameriwater for the device "MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS". The FDA issued a decision of Substantially Equivalent on August 14, 2003. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Ameriwater has at least 10 other 510(k) clearances on record.