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

    MAGSTIM DOUBLE 70-2 COIL

    K Number: K130403 · Decision Aug 23, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    13
    Review Days
    185

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    Basic Information

    Device Name
    MAGSTIM DOUBLE 70-2 COIL
    K Number
    K130403
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Magstim Company , Ltd.
    Date Received
    February 19, 2013
    Decision Date
    August 23, 2013
    Product Code
    GWF
    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
    GWF Stimulator, Electrical, Evoked Response

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    Other Clearances by The Magstim Company , Ltd.

    K Number Device Name
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    K083242 NEUROSIGN AVALANCHE MOTOR NERVE MONITOR
    K080499 MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
    K071349 NEUROSIGN LARYNGEAL ELECTRODES
    K051864 MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
    K053141 NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800
    K991583 NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
    K980148 NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
    K964869 NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
    K945799 NEUROSIGN 100 IMPEDANCE METER
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