§870.2675. Oscillometer.
21 C.F.R. § 870.2675
Identification. An oscillometer is a device used to measure physiological oscillations of any kind, e.g., changes in the volume of arteries.
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.
Notes, amendments, and revision history
Amendments
[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.
Amendments
[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]