[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: 21CFR884.2720]

[Page 435]
 
                        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 C--Obstetrical and Gynecological Monitoring Devices
 
Sec. 884.2720  External uterine contraction monitor and accessories.

    (a) Identification. An external uterine contraction monitor (i.e., 
the tokodynamometer) is a device used to monitor the progress of labor. 
It measures the duration, frequency, and relative pressure of uterine 
contractions with a transducer strapped to the maternal abdomen. This 
generic type of device may include an external pressure transducer, 
support straps, and other patient and equipment supports.
    (b) Classification. Class II (performance standards).