GroundRules
21 CFR 876.1400: Stomach pH electrode.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
- Subpart B—Diagnostic Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON