[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: 21CFR882.1610]

[Page 399]
 
                        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. 882.1610  Alpha monitor.

    (a) Identification. An alpha monitor is a device with electrodes 
that are placed on a patient's scalp to monitor that portion of the 
electroencephalogram which is referred to as the alpha wave.
    (b) Classification. Class II (performance standards).