[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: 21CFR882.1880]

[Page 416-417]
 
                        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. 882.1880  Evoked response mechanical stimulator.

    (a) Identification. An evoked response mechanical stimulator is a 
device used to produce a mechanical stimulus or a

[[Page 417]]

series of mechanical stimuli for the purpose of measuring a patient's 
evoked response.
    (b) Classification. Class II (performance standards).