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510(k) Data Aggregation
K Number
K012069Device Name
MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
Manufacturer
NEUROTRON MEDICAL, INC.
Date Cleared
2001-08-01
(30 days)
Product Code
JXE
Regulation Number
882.1550Why 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.
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