BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    ELPHA 4 CONTI

    K Number: K032988 · Decision Dec 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    4
    Review Days
    70

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    Basic Information

    Device Name
    ELPHA 4 CONTI
    K Number
    K032988
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Danmeter A/S
    Date Received
    September 24, 2003
    Decision Date
    December 3, 2003
    Product Code
    KPI
    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
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

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    Other Clearances by Danmeter A/S

    K Number Device Name
    K042315 CEREBRAL STATE MONITOR - CSM
    K032954 ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80
    K032955 AUTOMOVE, MODEL AM800