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510(k) Data Aggregation

    K Number
    K090886
    Device Name
    RTX 3371
    Manufacturer
    TUNSTALL HEALTHCARE
    Date Cleared
    2009-04-15

    (15 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    TUNSTALL HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RTX3371 is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The RTX3371 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management centre or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) using standard wireless technologies. The RTX3371 does not measure, interpret or make any decisions on the vital data that it conveys.
    Device Description
    The RTX3371 device performs transmission of physiological patient information to and from wireless, infrared and cabled patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols. The RTX3371, with its build-in GSM/GPRS module, transmits data using public wireless networks. The RTX3371 screen, displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons The RTX3371 device is not used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.
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