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

    CONCENTRIC ELECTRODE TYPE #13R01, 13R02

    K Number: K895460 · Decision Jun 18, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    42
    Applicant Total
    12
    Review Days
    285

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    Basic Information

    Device Name
    CONCENTRIC ELECTRODE TYPE #13R01, 13R02
    K Number
    K895460
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1385
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Dantec Electronics, Inc.
    Date Received
    September 6, 1989
    Decision Date
    June 18, 1990
    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 Dantec Electronics, Inc.

    K Number Device Name
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    K874759 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE
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