HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM

HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM is an FDA 510(k)-cleared medical device (K022747) manufactured by Hydropure Systems, 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 February 10, 2003. Regulation: 8.