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

    Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm

    K Number: K143433 · Decision Aug 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    42
    Applicant Total
    4
    Review Days
    270

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    Basic Information

    Device Name
    Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
    K Number
    K143433
    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
    December 1, 2014
    Decision Date
    August 28, 2015
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IKT), ordered by most recent decision date.

    Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)

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    Other Clearances by Natus Manufacturing Limited

    K Number Device Name
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