[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.2675]

[Page 434]
 
                        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. 884.2675  Fetal scalp circular (spiral) electrode and applicator.

    (a) Identification. A fetal scalp circular (spiral) electrode and 
applicator is a device used to obtain a fetal electrocardiogram during 
labor and delivery. It establishes electrical contact between fetal skin 
and an external monitoring device by a shallow subcutaneous puncture of 
fetal scalp tissue with a curved needle or needles. This generic type of 
device includes nonreusable spiral electrodes and reusable circular 
electrodes.
    (b) Classification. Class II (performance standards).