ECMO-TEMP (TM) BLOOD WARMING DEVICE

ECMO-TEMP (TM) BLOOD WARMING DEVICE is an FDA 510(k)-cleared medical device (K873699) manufactured by Seabrook Medical Systems, 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 December 21, 1987. Regulation: 8.