HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL

HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL is an FDA 510(k)-cleared medical device (K904967) manufactured by Gambro-Hosp-Cobe, 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 27, 1991. Regulation: 8.