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

    MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00

    K Number: K051864 · Decision Dec 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    13
    Review Days
    166

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
    K Number
    K051864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Magstim Company , Ltd.
    Date Received
    July 8, 2005
    Decision Date
    December 21, 2005
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GWF), ordered by most recent decision date.

    SafeOp 3: Neural Informatix System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Nicolet EDX

    FDA 510(k)
    FDA Class 2 ·Neurology

    Natus Ultrapro S100 (982A0594)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Delphi Stimulator

    FDA 510(k)
    FDA Class 2 ·Neurology

    SafeOp 3: Neural Informatix Systeem

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    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
    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
    Search all 13 clearances from The Magstim Company , Ltd. →