3M Bair Hugger Temperature Management System (Model 675)

3M Bair Hugger Temperature Management System (Model 675) is an FDA 510(k)-cleared medical device (K210603) manufactured by 3M Company. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 2021. Regulation: 8.