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510(k) Data Aggregation
K Number
K974010Device Name
ADVANTAGE EMG SYSTEM, MODEL #A100
Manufacturer
Date Cleared
1998-01-16
(87 days)
Product Code
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Advantage EMG System, Model #A100 is a Diagnostic Electromyography (EMG)/Evoked Response Electrical Stimulation System for the diagnosis of nervous and muscular system disorders in adult and pediatric patients.
Device Description
The technological characteristics remain unchanged as a result of the modification to the device. Using surface electrodes, signals are recorded from the surface of the skin, or directly from the nerves or muscles by means of needle electrodes. It is also possible to provide a timed stimulus to the patient, so that the response to the stimulus can be recorded and analyzed. The signals from the subject are taken through the headbox to the control modules and the computer for display and analysis. The computer is based on the Intel XX086 architecture. The only modification made to the device is the removal of diodes contained in the pre-amplifier circuitry.
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K Number
K973355Device Name
ADVANTAGE 3000
Manufacturer
Date Cleared
1997-12-05
(88 days)
Product Code
Regulation Number
890.1375Why did this record match?
Applicant Name (Manufacturer) :
ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Advantage 3000 system diagnoses disorders of the nervous and muscular systems.
The Advantage 3000 is a Diagnostic Electromyography/Evoked Response Electrical Stimulation (EMG/EP) System designed for the monitoring and analysis of electromyography data. A variety of electrophysiologic tests can be performed to determine whether disease of peripheral nerves or muscles is present in adult and pediatric patients.
Device Description
Using surface electrodes, signals are recorded from the surface of the skin or directly from the nerves or muscles by means of needle electrodes. It is also possible to provide a timed stimulus to the patient, so that the response to the stimulus can be recorded and analysed. The signals from the subject are taken through the headbox to the control module and the computer for display and analysis. The computer is based on the Intel Pentium architecture. Differences from the predicate device are the inclusion of a constant voltage stimulator, a more efficient operating interface, a reduction in the wattage of the speaker, the availability of a portable system, and the size reduction of the laboratory based system. Beyond these differences both devices have the same technological characteristics.
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