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510(k) Data Aggregation
K Number
K202739Device Name
Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System
Manufacturer
Bioland Technology Ltd.
Date Cleared
2022-08-12
(693 days)
Product Code
NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
Bioland Technology Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bioland G-425-2V Blood Glucose Monitoring System is comprised of Bioland G-425-2V blood glucose meter and Bioland Blood Glucose Test Strips.
The Bioland G-425-2V Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Bioland Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Bioland G-425-2V Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland G-425-2V Blood Glucose Monitoring System is not for use in neonates.
The Bioland G-425-2 Blood Glucose Monitoring System is comprised of Bioland G-425-2 blood glucose meter and Bioland Blood Glucose Test Strips.
The Bioland G-425-2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Bioland Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Bioland G-425-2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland G-425-2 Blood Glucose Monitoring System is not for use in neonates.
Device Description
The Bioland G-425-2V Blood Glucose Monitoring System consists of three main components: the meter (with voice feature , no Bluetooth features), test strip and control solutions. Bioland Blood Glucose Test Strips (Test strips are the same as k191657) and Bioland Glucose Control Solution (Control solution are the same as K191657) can be used with the Bioand G-425-2V Blood Glucose Monitoring System.
The Bioland G-425-2 Blood Glucose Monitoring System consists of three main components: the meter (No voice feature, no Bluetooth features), test strip and control solutions. Bioland Blood Glucose Test Strips (Test strips are the same as k191657) and Bioland Control Solution (Control solution are the same as k191657) can be used with the Bioland G-425-2 Blood Glucose Monitoring System.
The Bioland G-425-2V / G-425-2 Blood Glucose Monitoring System consists of:
- a) Bioland G-425-2V / G-425-2 Blood Glucose Meter;
- Bioland Blood Glucose Test Strips; b)
- C) Bioland Glucose Control Solution;
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K Number
K213011Device Name
Infrared Thermometer (model: E201)
Manufacturer
Bioland Technology Ltd
Date Cleared
2022-04-05
(197 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Bioland Technology Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Infrared Thermometer (model: E201) is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1~5cm. The device can be used by consumers in homecare environment.
Device Description
The Infrared Thermometer, model E201, is a light weight, handheld and reusable infrared thermometer that measures temperatures for people of all ages by detecting infrared energy radiated from the forehead and auditory canal in the homecare environment. It uses 3.0V alkaline batteries and can be operated continuously. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's forehead mode, the thermometer must keep 1-5 cm distance with the forehead of patient, a probe cover is not needed for the forehead and ear mode. The reference body site of E201 infrared thermometer is oxter (axillary). The device has the following features: 1) The device is intended to be used in the homecare environment; 2) The device is mainly composed of infrared sensor(Thermopile), signal receiving processor, buttons, buzzer, LCD display. It is powered by 2*1.5 AAA batteries; 3) Switching between °C and °F; 4) Multi-functional, can measure ear and forehead temperature; 5) The 32 sets measurement data can be stored, the user can view the previous measurement results; 6) Low battery indication, and auto shut-down within 30s.
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K Number
K201879Device Name
Digital Thermometer Model T103, T104
Manufacturer
Bioland Technology Ltd.
Date Cleared
2021-03-31
(267 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Bioland Technology Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The digital thermometer intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.
Device Description
The digital thermometer is an electronic thermometer using a thermistor to measure human body temperature for people of all ages. The digital thermometer are designed to be non-sterile, reusable clinical thermometers intended for the determination of human body temperature by contact the sensing probe with patient's axillary and oral. The measurement duration is less than 1 minute. The device has a storage function in which the last measured value is automatically stored after measurement is successfully completed. This device is designed for people of all ages to use at home. There is BF applied part. No special protection against the use in the environment of ignitable gases.
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K Number
K202934Device Name
Blood Pressure Monitor
Manufacturer
Bioland Technology Ltd.
Date Cleared
2021-01-26
(119 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Bioland Technology Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Device Description
The 2008, A221-2 blood pressure monitor contains shell, button, display screen, air tube, cuff and battery. The systolic, diastolic blood pressures and heart beats are transmitted via air pressure in the inflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by air pump. The deflation rate is controlled and released by a preset mechanical valve at a constant rate beginning at the pressure peak during the measurement. The measurement results including diastolic, systolic pressures and heart pulse rate are displayed on the LCD.
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K Number
K201161Device Name
Infrared Thermometer Model E127
Manufacturer
Bioland Technology Ltd.
Date Cleared
2020-10-02
(155 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Bioland Technology Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Infrared thermometer is a non-sterile, reusable, handheld and non-contact device. It can be used by consumers in home care environment and doctors in clinic as reference. It is intended for measuring human body temperature of one month of age and above by detecting infrared heat from the forehead.
Device Description
The Infrared Thermometer, Model E127, is a light weight, handhold and non-contact Infrared Thermometer that measures temperatures of people ages 1 month and above by detecting the infrared energy radiated directly from the forehead without physical contact from a measurement distance of 1-5cm. . It uses 3.0V alkaline batteries. The device can measure temperature in direct and adjusted mode.
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K Number
K201467Device Name
Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B
Manufacturer
Bioland Technology Ltd.
Date Cleared
2020-09-21
(111 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Bioland Technology Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Device Description
The 2006-2B, 2006, 2006, 2005 blood pressure monitor contains shell, button, display screen, air tube, cuff and battery. The systolic blood pressures and heart beats are transmitted via air pressure in the inflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by air pump. The deflation rate is controlled and released by a preset mechanical valve at a constant rate beginning at the pressure peak during the measurement. The measurement results including diastolic, systolic pressures and heart pulse rate are displayed on the LCD. The proposed device equipped with Bluetooth transmission function, which enable user to transmit the measurement results from the device to a mobile phone through Bluetooth. Users can manage the measurement results by the mobile application.
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K Number
K191657Device Name
Bioland Blood Glucose Monitoring System
Manufacturer
Bioland Technology Ltd.
Date Cleared
2020-03-20
(273 days)
Product Code
NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
Bioland Technology Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bioland Blood Glucose Monitoring System is comprised of Bioland Blood Glucose Meter and Bioland Blood Glucose Test Strips.
The Bioland Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Bioland Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Bioland Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland Blood Glucose Monitoring System is not for use in neonates.
Device Description
The Bioland Blood Glucose Monitoring System (hereafter as the System) is an in vitro diagnostic device intended for the measurement of glucose in capillary blood. The System consists of the Bioland Blood Glucose Meter, Bioland Blood Glucose Test Strips, lancing device / sterile lancet and Bioland Glucose Control Solution. The Bioland Glucose Control Solution is for use with the Bioland Blood Glucose Meter and Bioland Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. These products have been designed and tested to work together as a system to produce accurate blood glucose test results. The measured result can be transferred to the appointed equipment that has been connected via the Bluetooth function.
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K Number
K083681Device Name
BIOLAND BLOOD PRESSURE MONITOR
Manufacturer
BIOLAND TECHNOLOGY LTD.
Date Cleared
2009-01-16
(35 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
BIOLAND TECHNOLOGY LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bioland Blood Pressure Monitor Model 2001, Model 2003, Model 2004, Model 2005, model 3000, Model 3001 and Model 3002, are Sphygmomanometer with Electronic Manometer ntended to be used for the indirect (non-invasive) measurement of diastohc, systolic blood pressure and pulse rate for adults only.
Device Description
Bioland Blood Pressure Monitor Model 2001, Model 2003, Model 2005, model 3000, Model 3001 and Model 3002, are Sphygmomanometers with Electronic Manometer intended to be used for the indirect (non-mvasive) measurement of diastohe, systolic blood pressure and pulse rate for adults only.
Bioland Blood Pressure Montor Model 2001 and Model 2004 respectively use an inflation cuff wrapped around the upper arm The cuff is inflated by a manual air pump
Bloland Blood Pressure Monitor Model 2003 and Model 2005 respectively use an inflation cuff wrapped around the upper arm. The cuff is inflated by an electrical air pump
Bioland Blood Pressure Montor Model 3000, Model 3002, respectively uses inflation cuffs wrapped around the wrists. The cuff is inflated automatically by an electrical arr pump
The systolic, diastolic blood pressures and heart beats are transmitted via air pressure in the mflated cuff to transducer for the determination with oscillometric method. The cuff integrated with bladder is inflated by arr pump The deflation rate is controlled and released by a preset mechanical valve at a constant rate beginning at the pressure peak during the measurement results including dastolic. systolic pressures and heart pulse rate are displayed on the LCD
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