BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    IceCap product line

    K Number: K243788 · Decision Mar 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    1
    Review Days
    94

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    Basic Information

    Device Name
    IceCap product line
    K Number
    K243788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bioserenity Medical Devices Group
    Date Received
    December 9, 2024
    Decision Date
    March 13, 2025
    Product Code
    GXY
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXY Electrode, Cutaneous

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