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510(k) Data Aggregation

    K Number
    K050128
    Device Name
    VITALWARE VMS
    Manufacturer
    TELEVITAL, INC.
    Date Cleared
    2005-05-13

    (114 days)

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

    TELEVITAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TeleVital VitalWare VMS is a vital sign monitoring and patient information software product intended to be used in conjunction with independent monitoring devices, and ancillary systems for the real-time collection, storage, and transmission to remote viewing sites. The system is intended to be used in a hospital or clinic environment. Clinical judgment and experience are required to check and interpret the information delivered. VitalWare VMS is not intended to, and is not capable of controlling any of the medical devices it interfaces with.
    Device Description
    The TeleVital VitalWare VMS is a software system utilized for the real-time collection, storage, transmission, surveillance and management of vital sign data. The system can be used with any supported monitoring device or ancillary system connected directly to a PC computer or a network. The vital sign data is made available on any workstation on the network and/or Internet allowing health care professionals at the point of care to receive assistance from a supplementary care location. A typical deployment is composed of more than one PC workstation connected to one or more servers, receiving data from one or more medical devices over a network.
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