[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: 21CFR884.2640]

[Page 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. 884.2640  Fetal phonocardiographic monitor and accessories.

    (a) Identification. A fetal phonocardiographic monitor is a device 
designed to detect, measure, and record fetal heart sounds 
electronically, in graphic form, and noninvasively, to ascertain fetal 
condition during labor. This generic type of device includes the 
following accessories: signal analysis and display equipment, patient 
and equipment supports, and other component parts.
    (b) Classification. Class II (performance standards).