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510(k) Data Aggregation

    K Number
    K023078
    Device Name
    BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR
    Manufacturer
    VSM MEDTECH LTD.
    Date Cleared
    2003-03-21

    (186 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    VSM MEDTECH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BpTRU Vital Signs Monitor (Model BPM-300): - Measures systolic and diastolic blood pressure and pulse rate in subjects 3 . years of age or older. - Measure temperatures in subjects 3 years of age or older. ● - Is intended for use in physicians' offices, nursing units, and patient care areas . of hospitals. The BpTRU is intended to: - measure systolic and diastolic blood pressure and pulse rate in subjects . - measure systolic blood pressure in the range of 60 to 250 mmHg. ● - measure diastolic blood pressure in the range of 40 to 160 mmHg. ● - measure pulse rate in the range of 40 to 200 beats per minute. . - measure temperature in the range of 28°C to 43°C (82.4°F to 109.4°F) for ● Continuous (Monitoring) Measurements and 35°C to 39°C (95.0 to 102.2°F) for Predictive (Single) Measurements. - be operated by physicians, nurses, or other qualified medical personnel. ● - be used in physicians' offices, nursing units, and patient care areas of . hospitals. - . be pole-mounted, wall-mounted or used on a table top. - be battery or mains operated. . - be connected to a PC via a USB port for data interchange. .
    Device Description
    The BPM-300 is an automated, non-invasive blood pressure and temperature monitor that measures the blood pressure and pulse rate of patients using an upper arm cuff and the oral, axillary and rectal temperature using thermometry probes. The device uses standard blood pressure cuffs normally used in auscultation to measure the blood pressure in the upper arm. The device also uses stainless steel temperature probes, which are similar to design to commercially available probes from YSI, to measure the temperature from the oral, axillary and rectal regions. The BPM-300 has two blood pressure operational modes: Manual and Automatic, which are used with the oscillometric technique to calculate systolic and diastolic blood pressure. Manual Mode is designed to take a single blood pressure measurement. Automatic Mode takes six measurements, discards the first, and displays the average of the last five readings. The cycle time, or minutes between measurements (from the start of one measurement to the start of the next measurement), can be selected in Automatic Mode. Readings can be reviewed in both Manual and Automatic Modes. The BPM-300 includes two temperature measurement modes: Predictive and Continuous. Continuous Mode is designed to be used for taking extended length, monitoring measurements from the oral, axillary or rectal regions of the body. Predictive Mode is designed to calculate a single, quick (15 second) and accurate temperature measurement from either the oral or axillary region. There are two different color-coded temperature probes available for the BPM-300: oral/axillary (blue probe) and rectal (red probe). These temperature probes, which are manufactured for VSM by Yellow Springs Inc., also include the additional safety of a disposable probe cover, manufactured for VSM by Banta Healthcare. The BPM-300 incorporates a battery, which allows for portable operation, a polemounting feature and computer/interface connectivity feature, through a USB port.
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    K Number
    K023055
    Device Name
    BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200
    Manufacturer
    VSM MEDTECH LTD.
    Date Cleared
    2002-10-22

    (39 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    VSM MEDTECH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BpTRU BPM-200: - Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of age or older. - Is intended for use in physicians' offices, nursing units, and patient care areas of hospitals.
    Device Description
    The BpTRU Portable Automated Non-Invasive Blood Pressure Monitor (Model BPM-200) is a portable automated, non-invasive blood pressure monitor designed to measure the blood pressure and pulse rate of patients using an upper arm cuff. The device uses a standard blood pressure cuff to measure the blood pressure in the upper arm. The device automatically inflates and deflates the cuff, and uses the oscillometric technique to calculate systolic and diastolic blood pressure. The BPM-200 has two blood pressure operational modes: Manual and Automatic. Manual Mode is designed to take a single blood pressure measurement. Automatic Mode takes six measurements, discards the first, and displays the average of the last five readings. The cycle time, or minutes between measurements (from the start of one measurement to the start of the next measurement), can be selected in Automatic Mode. Individual readings are stored and can be reviewed in both Manual and Automatic Modes. The BPM-200 can be operated while mounted to a wall, attached to a roll-stand or self-standing on the tabletop. The new device includes an internal rechargeable battery and features USB connectivity.
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    K Number
    K994423
    Device Name
    AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
    Manufacturer
    VSM MEDTECH LTD.
    Date Cleared
    2000-03-28

    (90 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    VSM MEDTECH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BPM-100: - Measures systolic and diastolic blood pressure and pulse rate in adults greater than 18 years of age. - Is intended for use in physicians' offices, nursing units, and patient care areas of hospitals.
    Device Description
    Automated Non-Invasive Blood Pressure Monitor, Model BPM-100
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