BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+

    K Number: K223154 · Decision Mar 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    65
    Applicant Total
    10
    Review Days
    161

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    Basic Information

    Device Name
    Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
    K Number
    K223154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5805
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Magstim Company, Ltd.
    Date Received
    October 6, 2022
    Decision Date
    March 16, 2023
    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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    Other Clearances by Magstim Company, Ltd.

    K Number Device Name
    K222171 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
    K211389 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
    K203684 Neurosign V4 Intraoperative Nerve Monitor
    K183376 HORIZON TMS Therapy System with Navigation
    K182853 HORIZON TMS Therapy System
    K181559 Neurosign V4 Intraoperative Nerve Monitor
    K180907 HORIZON TMS Therapy System
    K171051 HORIZON Therapy System
    K162935 Rapid2 Therapy System