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

    MR Conditional Cup Electrode, MR Conditional Webb Electrode

    K Number: K172503 · Decision Dec 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    18
    Review Days
    105

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    Basic Information

    Device Name
    MR Conditional Cup Electrode, MR Conditional Webb Electrode
    K Number
    K172503
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rhythmlink International, LLC
    Date Received
    August 18, 2017
    Decision Date
    December 1, 2017
    Product Code
    GXY
    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
    GXY Electrode, Cutaneous

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