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510(k) Data Aggregation

    K Number
    K071109
    Device Name
    SACS EEG WORKSTATION A7
    Manufacturer
    Date Cleared
    2007-06-07

    (50 days)

    Product Code
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SACS MEDICAL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SACS EEG Workstation A7 is intended to be used for the measurement and recording of the electrical activity in a patient's brain, using electrodes placed on the patient's head. The SACS EEG Workstation A7 is intended for use by qualified medical personnel trained in the use of electroencephalographs.
    Device Description
    The SACS EEG Workstation A7 ("SACS A7") is a line-powered electroencephalograph that measures and records the electrical activity in a patient's brain via electrodes placed on the patient's head. The SACS A7 System device is comprised of a flat-panel monitor, an Intel Pentium-based computer with proprietary software installed, a separate EEG amplifier, a separate photic stimulator, and a standard computer keyboard. The components can be mounted on a customer's mobile stand or cart, or on a desk or work table. A USB cable connects the computer to the EEG amplifier, which is in turn connected to patient electrodes that are applied to specified locations on the patient's head. The system is controlled by a Windows XP-based operating system. EEG results are stored either on the Workstation itself in the SACS Database on the hard drive, or on a network server. If results are stored on the SACS Server Database on a network server, they can be reviewed from any SACS Review Workstation.
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