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

    Neurosign V4 Intraoperative Nerve Monitor

    K Number: K203684 · Decision Mar 17, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    34
    Applicant Total
    10
    Review Days
    90

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    Basic Information

    Device Name
    Neurosign V4 Intraoperative Nerve Monitor
    K Number
    K203684
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Magstim Company, Ltd.
    Date Received
    December 17, 2020
    Decision Date
    March 17, 2021
    Product Code
    PDQ
    Advisory Committee
    Ear, Nose, Throat
    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
    PDQ Neurosurgical Nerve Locator

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    Other Clearances by Magstim Company, Ltd.

    K Number Device Name
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    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
    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