BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    Myoject Luer Lock Needle Electrode

    K Number: K161430 · Decision Mar 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    42
    Applicant Total
    4
    Review Days
    283

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    Basic Information

    Device Name
    Myoject Luer Lock Needle Electrode
    K Number
    K161430
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1385
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Natus Manufacturing Limited
    Date Received
    May 23, 2016
    Decision Date
    March 2, 2017
    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 Natus Manufacturing Limited

    K Number Device Name
    K242346 Grass® MR Conditional/CT Cup Electrodes
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