OXITEMP, 3301T SA

OXITEMP, 3301T SA is an FDA 510(k)-cleared medical device (K960058) manufactured by Bci Intl., 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 May 14, 1996. Regulation: 8.