BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Delphi Stimulator

    K Number: K242345 · Decision Nov 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    Delphi Stimulator
    K Number
    K242345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantalx Neuroscience
    Date Received
    August 7, 2024
    Decision Date
    November 5, 2024
    Product Code
    GWF
    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
    GWF Stimulator, Electrical, Evoked Response

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