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 886—OPHTHALMIC DEVICES > SUBPART B—Diagnostic Devices (§886.1040 to §886.1945) > 886.1510—Eye movement monitor.

886.1510—Eye movement monitor.

(a) Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.
(b) Classification. Class II.