BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DIGITAL ELECTRONEUROMETER S-100

    K Number: K843924 · Decision Mar 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    158

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    Basic Information

    Device Name
    DIGITAL ELECTRONEUROMETER S-100
    K Number
    K843924
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Neurotron, Inc.
    Date Received
    October 5, 1984
    Decision Date
    March 12, 1985
    Product Code
    JXE
    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
    JXE Device, Nerve Conduction Velocity Measurement

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