(11 days)
Measures automatically human's Systolic, Diastolic blood pressure and heart rate uping the oscillometric method. All values can be read out in one LCD Panel.
The intended use of this over-the counter device is for age 16 and above,
H&L Full Automatic (NIBP) Blood Pressure Monitor
This document is an FDA 510(k) clearance letter for a non-invasive blood pressure measurement system (HL168N) and does not contain the acceptance criteria or a study describing device performance.
Therefore, I cannot provide the requested information. The letter only confirms that the device has been found substantially equivalent to a legally marketed predicate device.
To get the information you requested, you would typically need to refer to the 510(k) submission itself (which often includes performance data and acceptance criteria) or a separate technical report/study for the device.
§ 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).