Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012069
    Device Name
    MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
    Manufacturer
    NEUROTRON MEDICAL, INC.
    Date Cleared
    2001-08-01

    (30 days)

    Product Code
    JXE
    Regulation Number
    882.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROTRON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BREVIO is intended for use for the measurement of nerve response latency and amplitude in the diagnosis and monitoring of peripheral neuropathies. The BREVIO is intended to be used as a waveform display nerve conduction monitor. It displays the latency value derived from an action potential. The display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry has the complete waveform from which the latency value is derived and this is delivered to the digital storage oscilloscope for compete waveform display. The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the BREVIO to examine the features of the waveform generated by the stimuli. The physician can determine the action potential latency, amplitude configuration and duration.
    Device Description
    The BREVIO is a battery powered (4 AA batteries) hand held device that is utilized to perform motor and sensory nerve conduction testing on peripheral nerves in a clinical setting. It consists primarily of two units, a handheld processor with LCD screen and a stimulator. It may also be coupled with a number of HP inkjet printers to print patient information and results. The BREVIO automatically picks out the latency and amplitude of waveforms presented to determine the values associated with them. The automatically chosen values may be manually adjusted by the user should the user feel the necessity to manually make such a change. The BREVIO has memory storage of 28 waveforms for later viewing and printing of the test results.
    Ask a Question

    Page 1 of 1