[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: 21CFR884.2960]

[Page 426-427]
 
                        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. 884.2960  Obstetric ultrasonic transducer and accessories.

    (a) Identification. An obstetric ultrasonic transducer is a device 
used to apply ultrasonic energy to, and to receive ultrasonic energy 
from, the body in conjunction with an obstetric monitor or imager. The 
device converts

[[Page 427]]

electrical signals into ultrasonic energy, and vice versa, by means of 
an assembly distinct from an ultrasonic generator. This generic type of 
device may include the following accessories: coupling gel, 
preamplifiers, amplifiers, signal conditioners with their power supply, 
connecting cables, and component parts. This generic type of device does 
not include devices used to generate the ultrasonic frequency electrical 
signals for application.
    (b) Classification. Class II (performance standards).