TEMPTEK 5010 THERMAL COOLING BLANKET

TEMPTEK 5010 THERMAL COOLING BLANKET is an FDA 510(k)-cleared medical device (K891092) manufactured by Temptek, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 1989. Regulation: 8.