CarbonCool® System
K-Number: K240933 · 2025-03-18
ApplicantGlobal Healthcare SG Sdn. Bhd
Decision Date2025-03-18
Product CodeNZE
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CarbonCool® System is a medical device manufactured by Global Healthcare SG Sdn. Bhd. It received FDA 510(k) clearance on 2025-03-18 under approval number K240933. The device is classified under product code NZE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CarbonCool® System?
CarbonCool® System is a medical device that received FDA 510(k) clearance on 2025-03-18. It is manufactured by Global Healthcare SG Sdn. Bhd. The 510(k) number is K240933.
When was CarbonCool® System approved by the FDA?
CarbonCool® System received FDA 510(k) clearance on 2025-03-18, under approval number K240933.
What company makes CarbonCool® System?
CarbonCool® System is manufactured by Global Healthcare SG Sdn. Bhd.
What is the FDA product code for CarbonCool® System?
The FDA product code for CarbonCool® System is NZE.
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K250979Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)Zoll Circulation, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.