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

    UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1

    K Number: K083679 · Decision Sep 11, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    74
    Applicant Total
    1
    Review Days
    274

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    Basic Information

    Device Name
    UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1
    K Number
    K083679
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1375
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uroval
    Date Received
    December 11, 2008
    Decision Date
    September 11, 2009
    Product Code
    IKN
    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
    IKN Electromyograph, Diagnostic

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