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

    DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH

    K Number: K051357 · Decision Sep 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    2
    Review Days
    119

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    Basic Information

    Device Name
    DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH
    K Number
    K051357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Digitimer , Ltd.
    Date Received
    May 24, 2005
    Decision Date
    September 20, 2005
    Product Code
    GWF
    Advisory Committee
    Neurology
    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
    GWF Stimulator, Electrical, Evoked Response

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    Other Clearances by Digitimer , Ltd.

    K Number Device Name
    K172381 Digitimer DS7AP Constant Current Stimulator