Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K040581
    Device Name
    MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM
    Manufacturer
    VITEL NET
    Date Cleared
    2004-05-27

    (84 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITEL NET

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MedVizer™ ViTelCare Patient Monitoring System is intended to be used as a tool for an in-home patient that acquires, accumulates, and transmits a continuous self-assessment of physical condition, and other physiological vital signs information to a healthcare practitioner located remotely from the patient. The patient data is transmitted to 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. 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
    MedVizer™ ViTelCare 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
    K Number
    K000557
    Device Name
    MEDVIZER PACS, MODEL RELEASE 2000
    Manufacturer
    VITEL NET
    Date Cleared
    2000-04-24

    (66 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITEL NET

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1