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

    OCD MT Cap (85-00397-000)

    K Number: K231350 · Decision Jun 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    9
    Applicant Total
    7
    Review Days
    30

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    Basic Information

    Device Name
    OCD MT Cap (85-00397-000)
    K Number
    K231350
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5802
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuronetics
    Date Received
    May 9, 2023
    Decision Date
    June 8, 2023
    Product Code
    QCI
    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
    QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

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