[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: 21CFR884.2900]

[Page 418-419]
 
                        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. 884.2900  Fetal stethoscope.

    (a) Identification. A fetal stethoscope is a device used for 
listening to fetal heart sounds. It is designed to transmit

[[Page 419]]

the fetal heart sounds not only through sound channels by air 
conduction, but also through the user's head by tissue conduction into 
the user's ears. It does not use ultrasonic energy. This device is 
designed to eliminate noise interference commonly caused by handling 
conventional stethoscopes.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.