AQUADEX SYSTEM 100, MODEL A1100

AQUADEX SYSTEM 100, MODEL A1100 is an FDA 510(k)-cleared medical device (K040489) manufactured by Chf 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 April 26, 2004. Regulation: 8.