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510(k) Data Aggregation

    K Number
    K243746
    Device Name
    Delphi Amplifier
    Manufacturer
    QuantalX Neroscience
    Date Cleared
    2025-03-12

    (97 days)

    Product Code
    GWL, CLE
    Regulation Number
    882.1835
    Why did this record match?
    Applicant Name (Manufacturer) :

    QuantalX Neroscience

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Delphi Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals and to transmit them digitally to a computer. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc.). The device is not intended for use in life support systems.
    Device Description
    The Delphi Amplifier has been designed as a mobile recording device for EEG (electroencephalography) signals. It provides access to recorded data over a USB connection to external software over its signal driver interface. The Delphi Amplifier is powered via a USB connection and does not require any additional power source. The Delphi Amplifier supports EEG acquisition and storage by Referential DC input channels, and Parallel trigger input channels. The Delphi Amplifier enables connection of up to 48 referential channels and 8bit trigger input channel. Impedance values can be measured for all referential electrodes as well as the reference. An SDK (Software Development Kit) is available for direct amplifier communication. The device is powered by the USB port connection to a computer. The USB port supports interface to the computer running the SDK.
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