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

    DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE

    K Number: K874758 · Decision Apr 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    12
    Review Days
    148

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    Basic Information

    Device Name
    DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE
    K Number
    K874758
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Dantec Electronics, Inc.
    Date Received
    November 18, 1987
    Decision Date
    April 14, 1988
    Product Code
    FAP
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

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    Other Clearances by Dantec Electronics, Inc.

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    K881915 DANTEC MAGNETIC STIMULATOR
    K874759 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE
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    K872106 DANTEC COUNTERPOINT
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