[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: 21CFR884.1630]

[Page 431]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
       Subpart B--Obstetrical and Gynecological Diagnostic Devices
 
Sec. 884.1630  Colposcope.

    (a) Identification. A colposcope is a device designed to permit 
direct viewing of the tissues of the vagina and cervix by a telescopic 
system located outside the vagina. It is used to diagnose abnormalities 
and select areas for biopsy. This generic type of device may include a 
light source, cables, and component parts.
    (b) Classification. Class II (performance standards).