PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS

PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS is an FDA 510(k)-cleared medical device (K011005) manufactured by Pure Water Solutions, 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 31, 2002. Regulation: 8.