21 C.F.R. § 870.1130 Noninvasive blood pressure measurement system.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart B—Cardiovascular Diagnostic Devices
§ 870.1130 Noninvasive blood pressure measurement system.