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510(k) Data Aggregation

    K Number
    K190536
    Device Name
    Mediracer NCS
    Manufacturer
    Mediracer Oy
    Date Cleared
    2019-09-25

    (205 days)

    Product Code
    JXE
    Regulation Number
    882.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mediracer Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mediracer NCS is intended to measure sensory and motor neripheral nerves. The measured data can be utilized in evaluating patients suspected of having focal neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician.
    Device Description
    The Mediracer NCS is a hand-held NCS Device to stimulate and record the nerve responses from patient. The NCS Device is connected to the disposable surface electrodes with cables provided with the NCS Device. The NCS Device communicates via Bluetooth with a computer which is using The Mediracer Analysis Center (MAC) software. The computer uses the MAC software to store and handle the patient measurement data. With the NCS Device comes a charger and a docking station for charging the NCS Device. Also, solution includes a test module for checking the functionality of the whole test system.
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