[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR886.1640]

[Page 457]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 886--OPHTHALMIC DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 886.1640  Ophthalmic preamplifier.

    (a) Identification. An ophthalmic preamplifier is an AC-powered or 
battery-powered device intended to amplify electrical signals from the 
eye in electroretinography (recording retinal action currents from the 
surface of the eyeball after stimulation by light), electrooculography 
(testing for retinal dysfunction by comparing the standing potential in 
the front and the back of the eyeball), and electromyography (recording 
electrical currents generated in active muscle).
    (b) Classification. Class II.