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510(k) Data Aggregation

    K Number
    K112817
    Device Name
    MICROEEG SYSTEM
    Date Cleared
    2012-06-19

    (265 days)

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

    BIO-SIGNAL GROUP CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The microEEG® system is a portable 26 channel digital electroencephalography (EEG) collection and wireless data transfer device that is designed for use in hospitals and other medical environments. The system digitizes analogue EEG signals collected by 3rd party electrodes, amplifies them, and uses Bluetooth® wireless connectivity to transfer the EEG data to a dedicated host computer. It is important to note that the microEEG® system collects and manages EEG data only. The system does not analyze or interpret EEG data in any manner. Rather, all such EEG analysis and interpretation is performed by a medical professional/clinician.
    Device Description
    The microEEG® system is a portable 26 channel digital electroencephalography (EEG) collection and wireless data transfer device that is designed for use in hospitals and other medical environments. The system digitizes analogue EEG signals collected by 3rd party electrodes, amplifies them, and uses Bluetooth® wireless connectivity to transfer the EEG data to a dedicated host computer.
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