[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.2740]

[Page 426]
 
                        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. 884.2740  Perinatal monitoring system and accessories.

    (a) Identification. A perinatal monitoring system is a device used 
to show graphically the relationship between maternal labor and the 
fetal heart rate by means of combining and coordinating uterine 
contraction and fetal heart monitors with appropriate displays of the 
well-being of the fetus during pregnancy, labor, and delivery. This 
generic type of device may include any of the devices subject to 
Secs. 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. 
This generic type of device may include the following accessories: 
Central monitoring system and remote repeaters, signal analysis and 
display equipment, patient and equipment supports, and component parts.
    (b) Classification. Class II (performance standards).