BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DYNAMIC NEUROSCREENING DEVICE

    K Number: K141208 · Decision Jul 23, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    75

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    Basic Information

    Device Name
    DYNAMIC NEUROSCREENING DEVICE
    K Number
    K141208
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prosenex
    Date Received
    May 9, 2014
    Decision Date
    July 23, 2014
    Product Code
    LQW
    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
    LQW Test, Temperature Discrimination

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