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510(k) Data Aggregation

    K Number
    K132033
    Device Name
    BM3/BM3 PLUS
    Manufacturer
    Date Cleared
    2013-12-04

    (156 days)

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

    **NOBLITT **& RUELAND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bionet BM3/BM3 Plus Patient Monitor is intended for use by trained healthcare personnel to diagnose and monitor multiple physiological parameters of human patients. It can be used on patients from adults to neonates. The device is designed as a bedside and portable monitor that can operate in all professional medical facilities. Physiological data include but are not restricted to: end-tidal CO2, electrocardiogram, pulse oximetry, pulse rate, noninvasive blood pressure, temperature, and respiration. The data output is displayed on an LCD screen and/or through a built-in printer as numerical data or in waveform. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits. The device is not intended for use as an apnea monitor, and it is not intended for use during MRI or CT scans.
    Device Description
    The Bionet BM3/BM3 Plus Patient Monitor (BM3/BM3 Plus) is a multifunctional device that monitors vital signs of human patients from neonates to adults. Parameters monitored by BM3/BM3 Plus include end-tidal CO2 (EtCO2). electrocardiogram (ECG), pulse oximetry (SpOz), pulse rate, noninvasive blood pressure (NIBP), temperature, and respiration, Data output is displayed in numeric and/or wave form(s) on a color LCD screen. Selected parameters and waves can also be shown in print via a built-in 58 mm thermal printer. The device may sound an alarm when a monitored parameter falls outside preset upper or lower limits. BM3/BM3 Plus is compact and can be used in either stationary mode in all professional medical facilities or on the move in medical transport mode. Its energy source can come from AC input or lithium-ion battery. BM3/BM3 Plus LAN connection capability enables the device to be built into a monitoring system, so that one person can monitor several patients at a time.
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