[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: 21CFR874.4750]

[Page 355]
 
                        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 E--Surgical Devices
 
Sec. 874.4750  Laryngostroboscope.

    (a) Identification. A laryngostroboscope is a device that is 
intended to allow observation of glottic action during phonation. The 
device operates by focusing a stroboscopic light through a lens for 
direct or mirror reflected viewing of glottic action. The light and 
microphone that amplifies acoustic signals from the glottic area may or 
may not contact the patient.
    (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.

[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 
FR 38801, July 25, 2001]