21 C.F.R. § 876.1725 Gastrointestinal motility monitoring system.
Title 21 - Food and Drugs
(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).
Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart B—Diagnostic Devices
§ 876.1725 Gastrointestinal motility monitoring system.
