FDA 510(k) Applications for Medical Device Product Code "NZE"
(Hyperthermia Monitor)

FDA 510(k) Number Applicant Device Name Decision Date
K162523 BRAIN COOL AB The IQool System 05/03/2017
K100071 EMCOOLS EMERGENCY MEDICAL COOLING SYSTEMS AG EMCOOLSPAD 10/12/2010
K240933 Global Healthcare SG Sdn. Bhd CarbonCool« System 03/18/2025
K061023 LIFE RECOVERY SYSTEMS HD, LLC THERMOSUIT SYSTEM 09/20/2006
K231182 ZOLL Circulation, Inc Thermogard HQÖ Temperature Management System, Thermogard XP« Temperature Management System 11/03/2023


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