[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: 21CFR874.1060]

[Page 348]
 
                        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 (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. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996; 66 
FR 38800, July 25, 2001]