BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER

BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER is an FDA 510(k)-cleared medical device (K913734) manufactured by Augustine Medical, 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 October 22, 1991. Regulation: 8.