Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System

Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System is an FDA 510(k)-cleared medical device (K231182) manufactured by Zoll Circulation, 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 November 2, 2023. Regulation: 8.