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510(k) Data Aggregation

    K Number
    K990766
    Device Name
    CERSR ELECTROMYOGRAPHY SYSTEM
    Date Cleared
    1999-08-27

    (172 days)

    Product Code
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARASPINAL DIAGNOSTIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CERSR™ Electromyography System is used to monitor and display the bioelectric signals produced by muscles to aid in the diagnosis and prognosis of muscular disease or dysfunction.
    Device Description
    CERSR™ is an electromyography system. CERSR™ is substantially equivalent to legally marketed predicate electromyographic systems. Like most electromyographic systems. CERSR™ allows for the monitoring and displaying of the bioelectrical signals generated by muscles. CERSR™ is specifically designed for a real-time recording of muscle electrophysiology. Most electromyographic systems have at most five channels for monitoring and displaying the activity of several muscle groups simultaneously. The CERSR™ reduces the problems associated with too few channels and allows for a real-time recording from multiple locations by applying an array of surface electrodes over the anatomical region of interest. Each electrode is connected to its own channel with preamplifier, amplifier, buffers and filters. The CERSR™ produces a user display of the myoelectric signals. These recordings may viewed in one of three standard formats, as a typical waveform, RMS display or as a frequency spectral analysis plot.
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