ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS

ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS is an FDA 510(k)-cleared medical device (K981680) manufactured by Dayton Water Systems. 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 December 30, 1998. Regulation: 8.