(57 days)
Measures automatically 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 for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 8.7" to 12.6" ) .
H&L Full Automatic (NIBP) Blood Pressure Monitor
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a blood pressure monitor, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies the device name, trade name, indications for use, and regulatory information, but it does not detail performance acceptance criteria or the results of a study.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study.
§ 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).