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510(k) Data Aggregation

    K Number
    K191593
    Device Name
    Digital Automatic Blood Pressure Monitor MD36 Series
    Manufacturer
    Grandway Technology (Shenzhen) Limited
    Date Cleared
    2019-07-22

    (38 days)

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

    Grandway Technology (Shenzhen) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The upper arm blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken.
    Device Description
    Digital Automatic Blood Pressure Monitor MD36 Series (Subject Device) are non-invasive blood pressure measurement systems for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The Subject Device utilize the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading. The Subject Device equipped with Bluetooth transmission which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.
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    K Number
    K171379
    Device Name
    Digital Automatic Wrist Blood Pressure Monitor MD4300
    Manufacturer
    Grandway Technology (Shenzhen) Limited
    Date Cleared
    2018-04-10

    (334 days)

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

    Grandway Technology (Shenzhen) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken. You are also warned of possible existing irregular heartbeat.
    Device Description
    Digital Automatic Wrist Blood Pressure Monitor MD4300 (Subject Device) are non-invasive blood pressure measurement systems for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The Subject Device utilize the oscillometric methodology, in which an inflatable cuff is wrapped around the wrist of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading. The Subject Device equipped with Bluetooth transmission, which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.
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    K Number
    K163648
    Device Name
    Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series
    Manufacturer
    Grandway Technology (Shenzhen) Limited
    Date Cleared
    2017-07-07

    (196 days)

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

    Grandway Technology (Shenzhen) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.
    Device Description
    Digital Automatic Blood Pressure Monitor BPM41 Series and Digital Automatic Blood Pressure Monitor BPM45 Series (Subject Device) are non-invasive blood pressure measurement systems for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The Subject Device utilize the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.
    Ask a Question
    K Number
    K163679
    Device Name
    Digital Automatic Blood Pressure Monitor MD3600
    Manufacturer
    GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
    Date Cleared
    2017-06-07

    (162 days)

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

    GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The upper arm blood pressure monitor is used to carry out non-invasive measurement and monitoring of the arterial blood pressure values in adults. This allows you to quickly and easily measure your blood pressure, save the measured values and display the development and average values of the measured values taken.
    Device Description
    Digital Automatic Blood Pressure Monitor MD3600 (Subject Device) are non-invasive blood pressure measurement systems for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The Subject Device utilize the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading. The Subject Device equipped with Bluetooth transmission, which enable user to transfer the measurement record from the device to a mobile platform through Bluetooth. User can manage the measurement record by using the mobile application.
    Ask a Question
    K Number
    K163113
    Device Name
    Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
    Manufacturer
    GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
    Date Cleared
    2017-01-19

    (73 days)

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

    GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist.
    Device Description
    Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the wrist of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.
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    K Number
    K152483
    Device Name
    Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series
    Manufacturer
    GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
    Date Cleared
    2015-09-29

    (29 days)

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

    GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure on an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.
    Device Description
    Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading. The key components of device are: a pressure sensor, an electric valve and an electronic control module together with an electric pump.
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    K Number
    K151583
    Device Name
    Digital Automatic Wrist Blood Pressure Monitor MD3900
    Manufacturer
    GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
    Date Cleared
    2015-08-07

    (57 days)

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

    GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K151587
    Device Name
    Digital Automatic Wrist Blood Pressure Monitor MD3200
    Manufacturer
    GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
    Date Cleared
    2015-08-07

    (57 days)

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

    GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wrist blood pressure monitor is used to carry out non-invasive measurement and monitoring of arterial blood pressure values in human adults. This allows you to quickly and easily measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the wrist, save the measurements and display the development of the measurements.
    Device Description
    Digital Automatic Wrist Blood Pressure Monitor MD3200 is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the wrist of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.
    Ask a Question
    K Number
    K143735
    Device Name
    Digital Automatic Blood Pressure Monitor MD2300
    Manufacturer
    Grandway Technology (Shenzhen) Limited
    Date Cleared
    2015-07-23

    (205 days)

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

    Grandway Technology (Shenzhen) Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The upper arm blood pressure monitor is used for non-invasive measurement and monitoring for adult's arterial blood pressure. You can use it to measure your systolic and diastolic pressure, and pulse rate through an inflatable cuff wrapped around the upper arm. Quickly and easily, storing the results and displaying the progression of readings together with the average.
    Device Description
    Digital Automatic Blood Pressure Monitor MD2300 is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.
    Ask a Question
    K Number
    K150373
    Device Name
    Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0]
    Manufacturer
    GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
    Date Cleared
    2015-06-11

    (118 days)

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

    GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the upper arm.
    Device Description
    Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series is a non-invasive blood pressure measurement system for use by medical professional or at home. It is designed to measure the systolic and diastolic blood pressure, and pulse rate of an individual in each measurement and then display the readings on a digital panel. The device utilizes the oscillometric methodology, in which an inflatable cuff is wrapped around the upper arm of an individual, for blood pressure measurement. This means the monitor detects your blood's movement through your brachial artery and converts the movement into a digital reading.
    Ask a Question

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