[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: 21CFR884.2900]

[Page 455]
 
                        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 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 (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 884.9.

[45 FR 12684-12720, Feb. 26, 1980, as amended at 66 FR 38809, July 25, 
2001]