[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.2600]

[Page 452-453]
 
                        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

[[Page 453]]

separate fetal heart signals from maternal heart signals by analyzing 
electrocardiographic signals (electrical potentials generated during 
contraction 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).