BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇱 Israel

    Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System

    K Number: DEN170078 · Decision Aug 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    322

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    Basic Information

    Device Name
    Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
    K Number
    DEN170078
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.5802
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Brainways , Ltd.
    Date Received
    September 29, 2017
    Decision Date
    August 17, 2018
    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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