[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: 21CFR874.1120]

[Page 349]
 
                        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. 874.1120  Electronic noise generator for audiometric testing.

    (a) Identification. An electronic noise generator for audiometric 
testing is a device that consists of a swept frequency generator, an 
amplifier, and an earphone. It is intended to introduce a masking noise 
into the non-test ear during an audiometric evaluation. The device 
minimizes the non-test ear's sensing of test tones and signals being 
generated for the ear being tested.
    (b) Classification. Class II.