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510(k) Data Aggregation

    K Number
    K060712
    Device Name
    VITELCARE C-TURTLE PATIENT MONITORING SYSTEM
    Manufacturer
    VISUAL TELECOMMUNICATIONS NETWORK, INC.
    Date Cleared
    2006-04-19

    (34 days)

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

    VISUAL TELECOMMUNICATIONS NETWORK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ViTelCare™ C-Turtle Patient Monitoring System is intended to be a communication tool for an in-home patient that acquires, accumulates, and transmits vital signs information, self-assessment of physical condition, and other physiological data to a healthcare practitioner located remotely from the patient. The patient information is received and stored on the MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. The healthcare practitioner can contact the patient directly through a videoconference connection when desired. The communication connectivity between patient and healthcare practitioner is via a standard public telecommunications utility to the Internet. Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals.
    Device Description
    The ViTelCare™ C-Turtle Patient Monitoring System is a PC based Telemedicine system adapted to the collection, management, and communication of patient monitoring data from home and group care environments.
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    K Number
    K043368
    Device Name
    VITELCARE TURTLE, MODEL 400
    Manufacturer
    VISUAL TELECOMMUNICATIONS NETWORK, INC.
    Date Cleared
    2005-02-01

    (55 days)

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

    VISUAL TELECOMMUNICATIONS NETWORK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ViTelCare™ Turtle 400 Patient Monitoring System is intended to be a communication tool for an in-home patient that acquires, accumulates, and transmits vital signs information, selfassessment of physical condition, and other physiological data to a healthcare practitioner located remotely from the patient. The patient information is received and stored on the MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. The communication connectivity between patient and healthcare practitioner is via a standard public telecommunications utility to the Internet. Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals.
    Device Description
    The ViTelCare™ Turtle 400 Patient Monitoring System is a PC based Telemedicine system adapted to the collection, management, and communication of patient monitoring data from home and group care environments.
    Ask a Question

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