21 CFR 876.1400
§ 876.1400 Stomach pH electrode.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 876.1400, § 876.1400 Stomach pH electrode, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90276
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Full text
(a) Identification. A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube.
(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.