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510(k) Data Aggregation
(56 days)
This automatic blood pressure Is intended tomeasure systolic pressure, diastolic pressure and pulse rate through upper arm.Are expected to use in the home orin the hospital, intended for people over 12 years old. The Subject device is not intended to be diagnostic device.
The device has four series : U90B series (models including U90B ,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).
All of them have same Indications for use and similar technological characteristics. All the models in the same series have the same electrical circuit design, PCB layout, critical components and internal wiring. The differences between the four series are the appearance design, circuit diagram and the PCB layout. All of them have the same working principles, software design and the similar technical specification.
Urion Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual (at least 12 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic 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 main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 400 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of cuff.
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