{"data":{"id":"us/21-cfr-874.1800","jurisdiction":"us","citation":"21 CFR 874.1800","heading":"Air or water caloric stimulator.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 874—EAR, NOSE, AND THROAT DEVICES","Subpart B—Diagnostic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"f900d60b76c0b3ee0f7a46b920b8b456325930dca45406793e9e2932e6e93d70","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-874.1600","next":"us/21-cfr-874.1820"},"notice":"GroundRules: Original legal text. Not legal advice."}