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) > 882.1870—Evoked response electrical stimulator.

882.1870—Evoked response electrical stimulator.

(a) Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.
(b) Classification. Class II (performance standards).