21 CFR § 870.2675 - Oscillometer.

(a) Identification. An oscillometer is a device used to measure physiological oscillations of any kind, e.g., changes in the volume of arteries.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]