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

    ULTRASHARP CONCENTRIC NEEDLES

    K Number: K080914 · Decision Jul 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    42
    Applicant Total
    2
    Review Days
    105

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    Basic Information

    Device Name
    ULTRASHARP CONCENTRIC NEEDLES
    K Number
    K080914
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.1385
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rochester Electro Medical, Inc.
    Date Received
    April 1, 2008
    Decision Date
    July 15, 2008
    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 Rochester Electro Medical, Inc.

    K Number Device Name
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