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510(k) Data Aggregation

    K Number
    K030419
    Device Name
    VITERION 100 TELEHEALTH MONITOR
    Manufacturer
    VITERION TELEHEALTHCARE LLC
    Date Cleared
    2003-11-06

    (269 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITERION TELEHEALTHCARE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Viterion100 TeleHealth Monitor is a physiological monitoring system. The system collects, accumulates, transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and practitioner. It can record physiological information such as: - Blood Pressure/Pulse - Blood Hemoglobin Oxygen Saturation (SpO2) - Body Weight - Blood Glucose - Temperature - Respiratory Peak Flow
    Device Description
    The Viterion 100 TeleHealth Monitor is a physiological monitoring system. The system collects, accumulates, transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and practitioner. The physiological monitoring instruments, selected by the healthcare practitioner, operate in conjunction with the Patient Terminal located in the patient's home, a hospital room, nursing home, or other healthcare facility. The Patient Terminal connects to the server via a conventional telephone line or through the Ethernet. The Viterion 100 TeleHealth Monitor system is a software controlled physiological monitoring device for which the healthcare provider is remotely located from the patient. It is a tabletop unit that communicates with the healthcare provider via a server. The built-in interface allows monitoring of the data directly from the selected physiological instruments. It also allows manual entry of other physiological measurements for those instruments that do not directly connect to the system.
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