BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    CarbonCool® System

    K Number: K240933 · Decision Mar 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    347

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    Basic Information

    Device Name
    CarbonCool® System
    K Number
    K240933
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Global Healthcare SG Sdn. Bhd
    Date Received
    April 5, 2024
    Decision Date
    March 18, 2025
    Product Code
    NZE
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NZE Hyperthermia Monitor

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