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510(k) Data Aggregation

    K Number
    K082626
    Device Name
    PAM 3000
    Manufacturer
    WIRELESS 2000 RF & UWB TECHNOLOGIES LTD.
    Date Cleared
    2009-01-16

    (129 days)

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

    **WIRELESS 2000 RF **& UWB TECHNOLOGIES LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PAM™3000 system is intended to measure heart rate and respiration rate in adult patients, in a general care hospital environment including, nursing homes The system monitors presence or absence of a patient in bed (bed exit) The system also times the length of continuous patient motion or absence of patient motion
    Device Description
    The PAM™3000 System is intended for contact-less and wreless monitoring of bed occupancy, motion and heart and respiration rates of adult patients 11 healthcare facilities The system utilizes a hıghly sensitive UWB-based motion sensor to detect the motion of heart and thorax The system consists of a Bed Sensor Panel (BSP), placed under the patient's mattress, Repeater Base Stations (RBS) that are typically mounted around the hallways in facility, and the Central Computer Station (CCS) with plugged-in Central Base Station (CBS) The signal containing the patient's heart rate and respiration rate data, bed occupancy data, patient motion, and the alerts generated by system are displayed on a PC monitor using Wireless 2000's proprietary Graphic User Interface (GUI) software The Central Computer Station (CCS) is typically located at the nursing station
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