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510(k) Data Aggregation
K Number
K240933Device Name
CarbonCool® System
Manufacturer
Global Healthcare SG Sdn. Bhd
Date Cleared
2025-03-18
(347 days)
Product Code
NZE
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
Global Healthcare SG Sdn. Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients.
Device Description
Global Healthcare SG has developed the CarbonCool® products as a portable, non-invasive body cooling solution designed to enhance temperature reduction for adult patients. The CarbonCool® also enables more widespread applications by reducing treatment cost and increasing treatment flexibility and accessibility. The CarbonCool® System is a single use passive body cooling solution designed for medical and comfort cooling purposes. The CarbonCool® System utilizes the MPad™ which consist of multiple cooling-cells made of thermoplastic polyurethane, filled with high thermal conductivity material.
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