[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: 21CFR874.4770]

[Page 355-356]
 
                        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 (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter

[[Page 356]]

subject to the limitations in Sec. 874.9 only when used in the external 
ear canal.

[55 FR 48440, Nov. 20, 1990, as amended at 61 FR 1122, Jan. 16, 1996; 66 
FR 38801, July 25, 2001]