BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    ICS Dizcovery (1091)

    K Number: K242198 · Decision Feb 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    58
    Applicant Total
    1
    Review Days
    203

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    Basic Information

    Device Name
    ICS Dizcovery (1091)
    K Number
    K242198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Natus Medical Denmark Aps
    Date Received
    July 26, 2024
    Decision Date
    February 14, 2025
    Product Code
    GWN
    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
    GWN Nystagmograph

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