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510(k) Data Aggregation

    K Number
    K122013
    Device Name
    MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M)
    Manufacturer
    MICROLIFE CORP.
    Date Cleared
    2013-05-13

    (307 days)

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

    MICROLIFE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ ( BP4GAPO-2M ) 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 Cardio+ (BP4GAPO-2M) achieves its function by integrating the device with an iPhone, iPad, or iPod Touch. 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 via cable with the PC.
    Device Description
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Cardio+ (BP4GAPO-2M) 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 Cardio+ (BP4GAPO-2M) achieves its function by integrating the device with an iPhone, iPad, or iPod Touch. Because the device does not contain an LCD or other display components, it is necessary for the device to connect with an iPhone, iPad, or iPod Touch containing supporting software to constitute a complete blood pressure measure system. 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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    K Number
    K080337
    Device Name
    MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D
    Manufacturer
    MICROLIFE CORP.
    Date Cleared
    2008-05-13

    (95 days)

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

    MICROLIFE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D 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 upper arm. The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.
    Device Description
    Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive MAM (Microlife Average Mode) technique in which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure 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 detects the appearance of atrial fibrillation during measurement and the atrial fibrillation symbol "~ " is displayed on the LCD screen if any atrial fibrillation signal has been detected.
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    K Number
    K073397
    Device Name
    MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50)
    Manufacturer
    MICROLIFE CORP.
    Date Cleared
    2007-12-20

    (17 days)

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

    MICROLIFE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the 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.
    Device Description
    Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H(BP A50) is designed to measure the 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 upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure 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 detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol " irreqular heart beat signal has been detected.
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    K Number
    K073398
    Device Name
    MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100)
    Manufacturer
    MICROLIFE CORP.
    Date Cleared
    2007-12-20

    (17 days)

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

    MICROLIFE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Wrist Watch Blood Pressure Monitor, Model BP 3MK1-3 (BP W100) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. 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 BP3MK1-3(BP W100) is designed to measure the 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 an electronic capacitive pressure 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 detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol " irregular heart beat signal has been detected.
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    K Number
    K041411
    Device Name
    MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP
    Manufacturer
    MICROLIFE CORP.
    Date Cleared
    2004-07-21

    (55 days)

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

    MICROLIFE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Upper Arm Blood Pressure Monitor, Model BP 3BT0-AP, is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the 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.
    Device Description
    The Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-AP is designed to measure the 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 Upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure 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".
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    K Number
    K031024
    Device Name
    MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100
    Manufacturer
    MICROLIFE CORP.
    Date Cleared
    2003-11-14

    (228 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROLIFE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for monitoring PEF (Peak Expired Flow Rate) for patient home use. The device is designed for pediatric to adult patients. The simple device interface provides ease of use for pediatric patients. When the device is used to monitor lung conditions such as asthma, the user should be under the care of a licensed health care professional. A licensed health care professional's advice is required to understand the meaning and importance of the measurements reported by the device and how to decide on an appropriate treatment plan. This treatment plan will tell the patient what action to take when there are changes in their PEF measurements.
    Device Description
    The Microlife Electronic Peak Flow Monitor. Model PF-100. comprises a hand held microprocessor based unit, incorporating a removable micro medical digital volume transducer. The transducer consists of an acrylic tube with a freely rotating vane supported on jeweled bearings positioned between a fixed swirl plate and a cross bar. As air is passed through the transducer, a vortex is created by the swirl plate, which causes the low inertia vane to rotate. The rotation of the vane is detected by the interruption of an infrared beam which produces an electrical pulse train at the output of a phototransistor. The number of rotations is proportional to the volume of air passed through the turbine, and the rate of rotation is proportional to the flow rate.
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    K Number
    K030961
    Device Name
    MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
    Manufacturer
    MICROLIFE CORP.
    Date Cleared
    2003-09-12

    (169 days)

    Product Code
    LHD
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROLIFE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Digital Basal Thermometer is a device intended for measuring, and aiding in the monitoring and tracking of basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
    Device Description
    The Microlife Digital Basal Thermometer, which uses the Basal Temperature method can be used for helping in family planning in healthy adults by understanding their menstrual cycle and ovulation and interpreting basal temperature changes. This Thermometer provides easy, quick and highly accurate readings over the body temperature range. The body temperature is measured by the thermistor (inside the probe tip) and displayed as numbers on the LCD (liquid crystal diplay) through microprocessor of IC. The basic principle of this thermometer is that change of thermistor resistance, caused by changes of temperature, are converted to changes of frequency of R-C oscillator circuit. Therefore, temperature can be given by measuring the frequency of oscillator. For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.
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    K Number
    K021305
    Device Name
    MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRINTER
    Manufacturer
    MICROLIFE CORP.
    Date Cleared
    2002-06-28

    (65 days)

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

    MICROLIFE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1-5 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. This device can be used in connection with the Microlife Thermal Printer, Model PR 1KA1.
    Device Description
    The Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1-5 is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which as inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronics capacitive pressure 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".
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    K Number
    K020725
    Device Name
    MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1
    Manufacturer
    MICROLIFE CORP.
    Date Cleared
    2002-03-12

    (6 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROLIFE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
    Device Description
    The Microlife Digital Infrared Ear Thermometer, Model IR1DE1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Their operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces. The Microlife Digital Infrared Ear Thermometer, consists mainly of the five parts: - IR Thermopile Sensor a) - ASIC b) - E2 PROM IC C) - LCD and Blacklight d) - Kev "2. Buzzer" 1 e)
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    K Number
    K013485
    Device Name
    MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1
    Manufacturer
    MICROLIFE CORP.
    Date Cleared
    2002-01-17

    (90 days)

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

    MICROLIFE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1 with Optional Thermal Printer, Model PR 1KA1 is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. This device can be used in connection with the Microlife Thermal Printer.
    Device Description
    The Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1 is designed to measure the 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 upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure 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". An optional printer is included as an accessory which can be sold separately in a separate box with the printer user manual.
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