(18 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.
Not Found
This is a 510(k) clearance letter for a non-invasive blood pressure measurement system (HL168H, HL168J, HL168Q). The provided text indicates that the device is substantially equivalent to a legally marketed predicate device. However, it does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.
The letter only states that the device measures systolic, diastolic blood pressure, and heart rate using the oscillometric method for individuals aged 16 and above. It also mentions that the device is for over-the-counter use.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.
§ 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).