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    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    CAIs Sensor (CAIs-001)

    K Number: K241160 · Decision Dec 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    1
    Review Days
    231

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    Basic Information

    Device Name
    CAIs Sensor (CAIs-001)
    K Number
    K241160
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brainu Co., Ltd.
    Date Received
    April 26, 2024
    Decision Date
    December 13, 2024
    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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