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    K Number
    K111576
    Device Name
    NT 2000 LESIONING GENERATOR
    Manufacturer
    NEUROTHERM, INC.
    Date Cleared
    2011-09-20

    (106 days)

    Product Code
    GXD
    Regulation Number
    882.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROTHERM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NT 2000 is intended for use for lesioning of neural tissue. The NT 2000 is indicated for use in the peripheral nervous system. The NT 2000 is to be used only with FDA cleared NeuroTherm RF probes and Smith & Nephew SPINECATH and ACUTHERM catheters.
    Device Description
    The NeuroTherm NT 2000 is a desktop RF lesioning generator, which is used for the lesioning of neural tissue. The device is a second generation device that is a modification of the NeuroTherm NT 1000 (K052878) previously cleared by FDA. The NT 2000 is a multi-lesioning, 4 channel portable generator that can provide continuous or pulsed RF output at 460 KHz, monopolar or dual electrode modes, and a Simplicity mode for large lesion creation. The device includes sensory and motor stimulation functions to fine tune electrode placement for procedures, and is also designed to connect to various lesioning probes which are inserted into patients for lesioning of neural tissue during medical procedures. Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface as well as self diagnostics, calibration checks, and recordkeeping functions.
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    K Number
    K052878
    Device Name
    NT-1000
    Manufacturer
    NEUROTHERM, INC.
    Date Cleared
    2006-01-23

    (103 days)

    Product Code
    GXD
    Regulation Number
    882.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROTHERM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NT 1000 is intended for use to create lesions in neural tissue. The NT 1000 is to be used with separately approved lesion/temperature probes such as NeuroTherm radiofrequency probes, Smith & Nephew Spinecath™ and Acutherm™ catheters, and Radionics DiskTrode™ radiofrequency probes.
    Device Description
    Not Found
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