[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR882.1310]

[Page 397]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 882--NEUROLOGICAL DEVICES--Table of Contents
 
               Subpart B--Neurological Diagnostic Devices
 
Sec. 882.1310  Cortical electrode.

    (a) Identification. A cortical electrode is an electrode which is 
temporarily placed on the surface of the brain for stimulating the brain 
or recording the brain's electrical activity.
    (b) Classification. Class II (performance standards).