[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: 21CFR882.1410]

[Page 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. 882.1410  Electroencephalograph electrode/lead tester.

    (a) Identification. An electroencephalograph electrode/lead tester 
is a device used for testing the impedance (resistance to alternating 
current) of the electrode and lead system of an electroencephalograph to 
assure that an adequate contact is made between the electrode and the 
skin.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 882.9.

[44 FR 51730-51778, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 
1996; 66 FR 38807, July 25, 2001]