ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM

ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM is an FDA 510(k)-cleared medical device (K071104) manufactured by Flier'S Quality Water 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 January 13, 2008. Regulation: 8.