CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 882—NEUROLOGICAL DEVICES > SUBPART B—Neurological Diagnostic Devices (§882.1020 to §882.1950) > 882.1900—Evoked response auditory stimulator.

882.1900—Evoked response auditory stimulator.

(a) Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.
(b) Classification. Class II (performance standards).