[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: 21CFR874.1060]

[Page 335]
 
                        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. 874.1060  Acoustic chamber for audiometric testing.

    (a) Identification. An acoustic chamber for audiometric testing is a 
room that is intended for use in conducting diagnostic hearing 
evaluations and that eliminates sound reflections and provides isolation 
from outside sounds.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996]