MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS

MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS is an FDA 510(k)-cleared medical device (K021560) manufactured by Ameriwater. 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 August 13, 2003. Regulation: 8.