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510(k) Data Aggregation
K Number
K180435Device Name
Arm Blood Pressure Monitor
Manufacturer
Date Cleared
2019-01-03
(317 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Alicn Medical (Shenzhen), Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-32cm.Suitable for adults who over the age of 12.
Device Description
The arm blood pressure monitor model AES-U171, AES-U181, AES-U131 are sphygmomanometers with electronic manometer intended to be used for the indirect (noninvasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults who over the age of 12 (not for neonatal) . The inflatable cuff is wrapped around the upper arm of an individual. The systolic and diastolic blood pressures are transmitted via air pressure and determined by the transducer integrated on the monitor with the oscillometric method. The systolic and diastolic blood pressure values and pulse rate per minute are displayed on the LCD panel.
The monitors AES-U171, AES-U181 and AES-U131 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance, and AES-U171 have print function.
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K Number
K180207Device Name
Non-contact Infrared Thermometer
Manufacturer
Date Cleared
2018-11-28
(308 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Alicn Medical (Shenzhen), Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Non-contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of two months and above of people by detecting infrared heat from the center of the forehead.
Device Description
The thermometer measures the temperatures of people by detecting the energy. The external probe plays an important role in the measuring process. As soon as the thermometer is placed at the center of the forehead or the object with a distance of 15mm-50mm and the radiation sensor is activated, the measurement will be taken instantly by detection of the infrared heat.
The thermometer AET-R161 can be connected with FOND APP through Bluetooth. The FOND APP applies to mobile phones which systems are Android 4.3 and above, or IOS 8.0 and above, and can be downloaded from Google store (for Android 4.3 and above) or iPhone APP Store (for IOS 8.0 and above). The data measured with AET-R161 can be transmitted to the FOND APP, where data can be recorded, saved and shared.
The device principle of operation is described as below:
All object, solid, liquid or gas, emit energy by radiation. The intensity of this energy depends on the temperature of the object. The Infrared Thermometer is therefore able to measure the temperature of a person by the energy the person emits. This measurement can be taken by an external temperature probe on the device for analysis and register the ambient temperature. Therefore, as soon as the operator holds the thermometer near forehead and activates the radiation sensor, the measurement is taken instantly by detection of the infrared heat generated by the arterial blood flow. Body heat can therefore be measured without any interference from the heat of the surrounding environment.
The thermometer includes four models: AET-R161, AET-R171, AET-R1D2, AET-R1B1. They all have the following basic functions:
- Sound alarm if the temperature exceeds 37.8℃.
- LCD back-lighted digital screen.
- Data displayed in Celsius or Fahrenheit.
- Automatic stop (energy saver).
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