NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM

NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM is an FDA 510(k)-cleared medical device (K001811) manufactured by Neu-Ion, 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 October 24, 2000. Regulation: 8.