[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: 21CFR884.2700]

[Page 454]
 
                        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. 884.2700  Intrauterine pressure monitor and accessories.

    (a) Identification. An intrauterine pressure monitor is a device 
designed to detect and measure intrauterine and amniotic fluid pressure 
with a catheter placed transcervically into the uterine cavity. The 
device is used to monitor intensity, duration, and frequency of uterine 
contractions during labor. This generic type of device may include the 
following accessories: signal analysis and display equipment, patient 
and equipment supports, and component parts.
    (b) Classification. Class II (performance standards).