WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

WATER PURIFICATION SYSTEM FOR HEMODIALYSIS is an FDA 510(k)-cleared medical device (K980182) manufactured by Usfilter/Ionpure, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 15, 1998. Regulation: 8.