BIOCHEM MODEL 3302 NEWOX2 OXIMETER

BIOCHEM MODEL 3302 NEWOX2 OXIMETER is an FDA 510(k)-cleared medical device (K920083) 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 April 10, 1994. Regulation: 8.