AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)

AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) is an FDA 510(k)-cleared medical device (K982650) manufactured by Dideco S.P.A.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 1998. Regulation: 8.