21 C.F.R. § 874.1800 Air or water caloric stimulator.
Title 21 - Food and Drugs
(a) Identification. An air or water caloric stimulator is a device that delivers a stream of air or water to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produce involuntary eye movements that are measured and recorded by a nystagmograph. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §874.9. [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]
Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart B—Diagnostic Devices
§ 874.1800 Air or water caloric stimulator.
