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510(k) K240933

CarbonCool® System by Global Healthcare SG Sdn. Bhd — Product Code NZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2025
Date Received
April 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hyperthermia Monitor
Device Class
Class II
Regulation Number
870.5900
Review Panel
CV
Submission Type

Intended to monitor and reduce a patient's temperature to mild hypothermia (not to go below 32 degrees celsius. To induce mild hypothermia in hyperthermic patients e.g., heat stroke, fever (excluding fever related to head injury, cardiac arrest, or other severe medical conditions).

Other clearances for product code NZE

  • K250979 — Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Managem (October 15, 2025)
  • K231182 — Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Managem (November 3, 2023)
  • K162523 — The IQool System (May 3, 2017)
  • K100071 — EMCOOLSPAD (October 12, 2010)
  • K061023 — THERMOSUIT SYSTEM (September 20, 2006)