- (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.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996]