21 CFR 874.1800 — Stimulator, Caloric-Water

Ear, Nose, Throat (EN) · Part 874 Subpart B—Diagnostic Devices · § 874.1800

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.

Classification Rationale

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.

Product Codes