[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR882.1350]

[Page 433]
 
                        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. 882.1350  Needle electrode.

    (a) Identification. A needle electrode is a device which is placed 
subcutaneously to stimulate or to record electrical signals.
    (b) Classification. Class II (performance standards).