(29 days)
Manual inflate type blood pressure monitor for measurement of human's systolic, diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel. The intended use of this over-the counter device is for adult patients whose arm circumference is between 24-32cm (approx. 9.4" to 12.6").
H&L Full Automatic (NIBP) Blood Pressure Monitor, Trade Name : HL888BM
I'm sorry, but without further documentation in your provided text beyond this 510(k) summary, I am unable to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the only thing provided is a letter from the FDA regarding a particular device. This letter does not contain information on acceptance criteria, device performance, study details, ground truth establishment, or training set specifics.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).