21 CFR § 870.1130
Noninvasive blood pressure measurement system
June 25, 2020
(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).