[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.1080]

[Page 340]
 
                        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. 874.1080  Audiometer calibration set.

    (a) Identification. An audiometer calibration set is an electronic 
reference device that is intended to calibrate an audiometer. It 
measures the sound frequency and intensity characteristics that emanate 
from an audiometer earphone. The device consists of an acoustic cavity 
of known volume, a sound level meter, a microphone with calibration 
traceable to the National Bureau of Standards, oscillators, frequency 
counters, microphone amplifiers, and a recorder. The device can measure 
selected audiometer test frequencies at a given intensity level, and 
selectable audiometer attenuation settings at a given test frequency.
    (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]