[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: 21CFR884.2660]

[Page 425]
 
                        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. 884.2660  Fetal ultrasonic monitor and accessories.

    (a) Identification. A fetal ultrasonic monitor is a device designed 
to transmit and receive ultrasonic energy into and from the pregnant 
woman, usually by means of continuous wave (doppler) echoscopy. The 
device is used to represent some physiological condition or 
characteristic in a measured value over a period of time (e.g., 
perinatal monitoring during labor) or in an immediately perceptible form 
(e.g., use of the ultrasonic stethoscope). This generic type of device 
may include the following accessories: signal analysis and display 
equipment, electronic interfaces for other equipment, patient and 
equipment supports, and component parts. This generic type of device 
does not include devices used to image some relatively unchanging 
physiological structure or interpret a physiological condition, but does 
include devices which may be set to alarm automatically at a 
predetermined threshold value.
    (b) Classification. Class II (performance standards).