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510(k) Data Aggregation

    K Number
    K041308
    Device Name
    REMOTENURSE PATIENT MONITORING SYSTEM
    Manufacturer
    WEBVMC, LLC
    Date Cleared
    2004-06-28

    (42 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    WEBVMC, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device "RemoteNurse™ Patient Monitoring system" is a monitoring tool prescribed by a licensed physician when time-critical care is not required, and is intended for use to provide caregivers remote access to vital sign measurements of patients at home, as captured on commercially available medical devices designed for home use, and transmitted to a database retrieved from a secure website. It is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The device is contraindicated for patients with uncompensated heart failure, patients at high risk of life threatening arrhythmias, patients with recent myocardial infarctions, or patients requiring direct medical supervision or emergency intervention. The device is intended for patients who are willing and capable to self-administrate it. Clinical judgment and experience are required to check and interpret the information delivered. Typical devices that may be connected to RemoteNurse™ Patient Station are: Blood Pressure Monitor, Glucose Meter, Weight Scale, Pulse-oxidation, Peak Flow, ECG and PT/INR. Also, digital camera may be connected to RemoteNurse™ Patient Station. The unit supports up to 8 devices in the same time.
    Device Description
    The device "RemoteNurse™ Patient Monitoring system" is a monitoring tool prescribed by a licensed physician when time-critical care is not required, for the purpose of providing caregivers remote access to vital sign measurements of patients at home, as captured on commercially available medical devices designed for home use, and transmitted to a database retrieved from a secure website. It is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The device is contraindicated for patients with uncompensated heart failure, patients at high risk of life threatening arrhythmias, patients with recent myocardial infarctions, or patients requiring direct medical supervision or emergency intervention. The device is intended for patients who are willing and capable to self-administrate it. Clinical judgment and experience are required to check and interpret the information delivered. The RemoteNurse™ Patient Monitoring system consists of - (1) RemoteNurse™ Patient Station –which is a computer with a touch sensitive screen- for capturing patient's vital signs from devices manufactured by others, The RemoteNurse™ Patient Station provides a user interface for displaying reminder information as well as prompting for patient responses to pre-defined questions. - (2) RemoteNurse™ software application for capturing, storing and forwarding patient's vital signs to a secure website via either a standard telephone lines or LAN/WAN. - (3) RemoteAccess™ software application to allow caregiver to review patient's vital signs on the secure website, RemoteAccess™ software application allows for pre-defining limits above or below which it emails and/or pages the caregiver. - (4) Processor software application to manage the interface between RemoteNurse™ software application and the website. Typical devices that may be connected to RemoteNurse™ Patient Station are: Blood Pressure Monitor, Glucose Meter, Weight Scale, Pulse-oxidation, Peak Flow, ECG and PT/INR. Also, digital camera may be connected to RemoteNurse™ Patient Station. The unit supports up to 8 devices in the same time.
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