BIOCHEM MODEL 3301 NEWOX1 OXIMETER

BIOCHEM MODEL 3301 NEWOX1 OXIMETER is an FDA 510(k)-cleared medical device (K920082) manufactured by Biochem International, 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 January 6, 1993. Regulation: 8.