COBE HEAT EXCHANGER RESERVOIR MODULE

COBE HEAT EXCHANGER RESERVOIR MODULE is an FDA 510(k)-cleared medical device (K812093) manufactured by Cobe Laboratories, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 12, 1981. Regulation: 8.