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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Integrity V500 (Integrity, Integrity with VEMP)

    K Number: K242954 · Decision Dec 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    75
    Applicant Total
    5
    Review Days
    85

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    Basic Information

    Device Name
    Integrity V500 (Integrity, Integrity with VEMP)
    K Number
    K242954
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1900
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vivosonic, Inc.
    Date Received
    September 25, 2024
    Decision Date
    December 19, 2024
    Product Code
    GWJ
    Advisory Committee
    Neurology
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWJ Stimulator, Auditory, Evoked Response

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    Other Clearances by Vivosonic, Inc.

    K Number Device Name
    K080060 VIVOSONIC NEUROSCREEN
    K043396 INTEGRITY, MODEL V500
    K033108 VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
    K003364 VIVO 200 DPS VIVOSCAN