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510(k) Data Aggregation

    K Number
    K240933
    Device Name
    CarbonCool® System
    Manufacturer
    Global Healthcare SG Sdn. Bhd
    Date Cleared
    2025-03-18

    (347 days)

    Product Code
    NZE
    Regulation Number
    870.5900
    Why 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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