(30 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. 9.4" to 12.6" ) .
H&L Full Automatic (NIBP) Blood Pressure Monitor, Trade Name : HL888BF. 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.
This document is a 510(k) clearance letter from the FDA for a non-invasive blood pressure measurement system (HL888BF). It does not contain any information regarding acceptance criteria, study details, or performance data for the device.
Therefore, I cannot extract the requested information. The letter only confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
§ 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).