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

    NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR

    K Number: K964869 · Decision May 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    96
    Applicant Total
    13
    Review Days
    161

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    Basic Information

    Device Name
    NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
    K Number
    K964869
    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
    The Magstim Company , Ltd.
    Date Received
    December 4, 1996
    Decision Date
    May 14, 1997
    Product Code
    ETN
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ETN Stimulator, Nerve

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    Other Clearances by The Magstim Company , Ltd.

    K Number Device Name
    K232235 Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
    K130403 MAGSTIM DOUBLE 70-2 COIL
    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
    K945799 NEUROSIGN 100 IMPEDANCE METER
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