(20 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 use of this over-the-counter-device is for age 16 and above.
H&L Full Automatic (NIBP) Blood Pressure Monitor
This document is a letter from the FDA regarding the 510(k) premarket notification for the HL168GA and HL168GS Full Automatic Pressure Monitor. It confirms the device's substantial equivalence to legally marketed predicate devices. However, it does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert involvement, adjudication), or MRMC studies.
Therefore, I cannot provide the requested information based on the given text.
§ 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).