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510(k) Data Aggregation

    K Number
    K151869
    Device Name
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor
    Manufacturer
    MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND
    Date Cleared
    2015-09-02

    (55 days)

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

    MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF 1-2B is a device intended to measure the systolic and diastolic blood pressure, pulserate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the single upper arm. The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable. The device can also be used in connection with smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.
    Device Description
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method". The device detects the appearance of irregular heartbeat during measurement, and the symbol " " is displayed with the reading. The device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable. The device can also be used in connection with smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.
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    K Number
    K151330
    Device Name
    Microlife Wrist Watch Blood Pressure Monitor
    Manufacturer
    MICROLIFE INTELLECTUAL PROPERTY GmbH, SWITZERLAND
    Date Cleared
    2015-07-14

    (56 days)

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

    MICROLIFE INTELLECTUAL PROPERTY GmbH, SWITZERLAND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wrist Watch Blood Pressure Monitor, Model BP3NN1-3E is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist for a circumference range from 13.5 to 21.5cm. The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.
    Device Description
    Microlife Wrist Watch Blood Pressure Monitor, Model BP3NN1-3E is designed to measure systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method". The device can detect electrical signals while inflating . And the device has Irregular Heartbeat Detection (IHD) function. It detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol "MA" is displayed on the LCD screen if any irregular heart beat signal has been detected. In addition, the device has traffic light function.
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    K Number
    K140572
    Device Name
    MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
    Manufacturer
    MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND
    Date Cleared
    2014-07-02

    (118 days)

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

    MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R) is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual by using a non-invasive oscillometric technique in one inflatable cuff is wrapped around the single upper arm. The device detects the appearance of irregular heartbeat during measurements, and gives a warning signal with the reading once the irregular heartbeat is detected. The device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia. The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable with the PC.
    Device Description
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4X(R) is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well known technique in the market called the "oscillometric method". The device can accurately measure blood pressure in pregnant patients including those with known or suspected preeclampsia. The device detects the appearance of irregular heartbeat during measurement, and the symbol " " "is displayed after the measurement. In addition, the device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable.
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