[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: 21CFR876.1725]

[Page 378]
 
                        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. 876.1725  Gastrointestinal motility monitoring system.

    (a) Identification. A gastrointestinal motility monitoring system is 
a device used to measure peristalic activity or pressure in the stomach 
or esophagus by means of a probe with transducers that is introduced 
through the mouth into the gastrointestinal tract. The device may 
include signal conditioning, amplifying, and recording equipment. This 
generic type of device includes the esophageal motility monitor and 
tube, the gastrointestinal motility (electrical) system, and certain 
accessories, such as a pressure transducer, amplifier, and external 
recorder.
    (b) Classification. Class II (performance standards).