[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.4750]

[Page 342]
 
                        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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994]