BAIR HUGGER MODEL 600 UNIT, BLANKETS

BAIR HUGGER MODEL 600 UNIT, BLANKETS is an FDA 510(k)-cleared medical device (K950416) 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 August 28, 1995. Regulation: 8.