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

    NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1

    K Number: K083538 · Decision Dec 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    65
    Applicant Total
    7
    Review Days
    18

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    Basic Information

    Device Name
    NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
    K Number
    K083538
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5805
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuronetics
    Date Received
    November 28, 2008
    Decision Date
    December 16, 2008
    Product Code
    OBP
    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
    OBP Transcranial Magnetic Stimulator

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