BIOCHEM TEMPERATURE/ FIO2 MODULE

BIOCHEM TEMPERATURE/ FIO2 MODULE is an FDA 510(k)-cleared medical device (K910381) manufactured by Biochem International, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 1991. Regulation: 8.