[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: 21CFR874.1050]

[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. 874.1050  Audiometer.


    (a) Identification. An audiometer or automated audiometer is an 
electroacoustic device that produces controlled levels of test tones and 
signals intended for use in conducting diagnostic hearing evaluations 
and assisting in the diagnosis of possible otologic disorders.
    (b) Classification. Class II. Except for the otoacoustic emission 
device, the device is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter, if it is in compliance with 
American National Standard Institute S3.6-1996, ``Specification for 
Audiometers,'' and subject to the limitations in Sec. 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 64 FR 14831, Mar. 29, 1999]