BAIR HUGGER MODEL 630 CARDIAC BLANKET

BAIR HUGGER MODEL 630 CARDIAC BLANKET is an FDA 510(k)-cleared medical device (K964673) 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 June 25, 1997. Regulation: 8.