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

    NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar

    K Number: K212289 · Decision May 6, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    9
    Applicant Total
    8
    Review Days
    289

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    Basic Information

    Device Name
    NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
    K Number
    K212289
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5802
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuronetics, Inc.
    Date Received
    July 21, 2021
    Decision Date
    May 6, 2022
    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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    Other Clearances by Neuronetics, Inc.

    K Number Device Name
    K231926 NeuroStar Advanced Therapy System (All previously cleared models)
    K222230 NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
    K220127 NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
    K213543 NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
    K201158 NeuroStar Advanced Therapy
    K161519 NeuroStar TMS Therapy System
    K160703 NeuroStar TMS Therapy System