(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 age 16 and above.
Full Automatic (NIBP) Blood Pressure Monitor
I am sorry, but the provided text is a letter from the FDA and does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets them. This document is a clearance letter for a 510(k) premarket notification, indicating that the device has been found substantially equivalent to a predicate device. It does not include the specifics of the performance studies or the acceptance criteria used in those studies.
§ 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).