WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS is an FDA 510(k)-cleared medical device (K042797) manufactured by Gambro Renal Products. 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 March 8, 2005. Regulation: 8.