GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H

GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H is an FDA 510(k)-cleared medical device (K974899) manufactured by Gambro Healthcare. 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 September 22, 1998. Regulation: 8.