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21 CFR 876.1725

§ 876.1725 Gastrointestinal motility monitoring system.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 876.1725, § 876.1725 Gastrointestinal motility monitoring system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90283
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(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).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.