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510(k) Data Aggregation

    K Number
    K113446
    Device Name
    VIGNET TELEHEALTH MANAGER
    Manufacturer
    VIGNET INC.
    Date Cleared
    2012-07-16

    (238 days)

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

    VIGNET INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vignet TeleHealth Manager is an accessory software application that is intended to be used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Vignet Telehealth Manager is intended to be used in combination with a variety of external vital sign devices. The Vignet TeleHealth Manager does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.
    Device Description
    The Vignet TeleHealth Manager is a software system that collects patient physiological data such as blood pressure and blood sugar levels for transmission to a secure central storage server which can be accessed by health care professionals for analysis and intervention using standard digital communication technologies and protocols. This data is also available to the patient for viewing purposes and as an aid in maintaining wellness regimens.
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