BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    DISPOSABLE NEEDLE ELECTRODE

    K Number: K961013 · Decision Dec 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    42
    Applicant Total
    15
    Review Days
    282

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    Basic Information

    Device Name
    DISPOSABLE NEEDLE ELECTRODE
    K Number
    K961013
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1385
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medelec Intl. Corp.
    Date Received
    March 13, 1996
    Decision Date
    December 20, 1996
    Product Code
    IKT
    Advisory Committee
    Physical Medicine
    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
    IKT Electrode, Needle, Diagnostic Electromyograph

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    Other Clearances by Medelec Intl. Corp.

    K Number Device Name
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