[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: 21CFR874.4770]

[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. 874.4770  Otoscope.

    (a) Identification. An otoscope is a device intended to allow 
inspection of the external ear canal and tympanic membrane under 
magnification. The device provides illumination of the ear canal for 
observation by using an AC- or battery-powered light source and an 
optical magnifying system.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter only 
when used in the external ear canal.

[55 FR 48440, Nov. 20, 1990, as amended at 61 FR 1122, Jan. 16, 1996]]