[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: 21CFR884.4340]

[Page 439]
 
                        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 E--Obstetrical and Gynecological Surgical Devices
 
Sec. 884.4340  Fetal vacuum extractor.

    (a) Identification. A fetal vacuum extractor is a device used to 
facilitate delivery. The device enables traction to be applied to the 
fetal head (in the birth canal) by means of a suction cup attached to 
the scalp and is powered by an external vacuum source. This generic type 
of device may include the cup, hosing, vacuum source, and vacuum 
control.
    (b) Classification. Class II (performance standards).