GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H is an FDA 510(k)-cleared medical device (K093608) manufactured by Gambro Renal Products, 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 July 28, 2010. Regulation: 8.