(28 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 age 16 and above.
Full Automatic (NIBP) Blood Pressure Monitor
The provided document is an FDA 510(k) clearance letter for a non-invasive blood pressure measurement system (HL168F). It confirms the device's substantial equivalence to a predicate device but does not contain the detailed acceptance criteria or the study that proves the device meets those criteria.
The document primarily focuses on regulatory approval and mentions the device's intended use and classification. It does not provide information about performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot extract the requested information from the provided 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).