[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: 21CFR874.1325]

[Page 341]
 
                        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. 874.1325  Electroglottograph.

    (a) Identification. An electroglottograph is an AC-powered device 
that employs a pair of electrodes that are placed in contact with the 
skin on both sides of the larynx and held in place by a collar. It is 
intended to measure the electrical impedance of the larynx to aid in 
assessing the degree of closure of the vocal cords, confirm larygeal 
diagnosis, aid behavioral treatment of voice disorders, and aid research 
concerning the laryngeal mechanism.
    (b) Classification. Class II.