[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: 21CFR882.1320]

[Page 413-414]
 
                        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. 882.1320  Cutaneous electrode.

    (a) Identification. A cutaneous electrode is an electrode that is 
applied directly to a patient's skin either to record physiological 
signals (e.g., the

[[Page 414]]

electroencephalogram) or to apply electrical stimulation.
    (b) Classification. Class II (performance standards).