[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: 21CFR874.1100]

[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. 874.1100  Earphone cushion for audiometric testing.

    (a) Identification. An earphone cushion for audiometric testing is a 
device that is used to cover an audiometer earphone during audiometric 
testing to provide an acoustic coupling (sound connection path) between 
the audiometer earphone and the patient's ear.
    (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 Sec. 874.9.

[51 FR 40389, Nov. 9, 1986; 52 FR 18495, May 15, 1987, as amended at 52 
FR 32111, Aug. 25, 1987; 65 FR 2315, Jan. 14, 2000]