Search Results
Found 21 results
510(k) Data Aggregation
K Number
K191593Device 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
870.1130Why 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.
Ask a Question
K Number
K171379Device 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
870.1130Why 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.
Ask a Question
K Number
K163648Device 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
870.1130Why 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
K163679Device Name
Digital Automatic Blood Pressure Monitor MD3600
Manufacturer
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
Date Cleared
2017-06-07
(162 days)
Product Code
DXN
Regulation Number
870.1130Why 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
K163113Device 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
870.1130Why 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.
Ask a Question
K Number
K152483Device 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
870.1130Why 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.
Ask a Question
K Number
K151583Device 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
870.1130Why 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
K151587Device 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
870.1130Why 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
K143735Device Name
Digital Automatic Blood Pressure Monitor MD2300
Manufacturer
Grandway Technology (Shenzhen) Limited
Date Cleared
2015-07-23
(205 days)
Product Code
DXN
Regulation Number
870.1130Why 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
K150373Device 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
870.1130Why 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
Page 1 of 3