[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.2600]

[Page 416-417]
 
                        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. 884.2600  Fetal cardiac monitor.

    (a) Identification. A fetal cardiac monitor is a device used to 
ascertain fetal heart activity during pregnancy and labor. The device is 
designed to separate fetal heart signals from maternal heart signals by 
analyzing electrocardiographic signals (electrical potentials generated 
during contraction

[[Page 417]]

and relaxation of heart muscle) obtained from the maternal abdomen with 
external electrodes. This generic type of device may include an alarm 
that signals when the heart rate crosses a preset threshold. This 
generic type of device includes the ``fetal cardiotachometer (with 
sensors)'' and the ``fetal electrocardiographic monitor.''
    (b) Classification. Class II (performance standards).