[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: 21CFR876.1620]

[Page 361]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 876.1620  Urodynamics measurement system.

    (a) Identification. A urodynamics measurement system is a device 
used to measure volume and pressure in the urinary bladder when it is 
filled through a catheter with carbon dioxide or water. The device 
controls the supply of carbon dioxide or water and may also record the 
electrical activity of the muscles associated with urination. The device 
system may include transducers, electronic signal conditioning and 
display equipment, a catheter withdrawal device to enable a urethral 
pressure profile to be obtained, and special catheters for urethral 
profilometry and electrodes for electromyography. This generic type of 
device includes the cystometric gas (carbon dioxide) device, the 
cystometric hydrualic device, and the electrical recording cystometer, 
but excludes any device that uses air to fill the bladder.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998]