[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: 21CFR874.1800]

[Page 336]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 874--EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 874.1800  Air or water caloric stimulator.

    (a) Identification. An air or water caloric stimulator is a device 
that delivers a stream of air or water to the ear canal at controlled 
rates of flow and temperature and that is intended for vestibular 
function testing of a patient's body balance system. The vestibular 
stimulation of the semicircular canals produce involuntary eye movements 
that are measured and recorded by a nystagmograph.
    (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 Sec. 874.9.

[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]