eCFR Reference Browser

---

title: "21 CFR §876.1400"

source: "https://www.ecfr.gov/current/title-21/section-876.1400"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "876"

part_subject: "GASTROENTEROLOGY-UROLOGY DEVICES"

subpart_code: "B"

subpart_subject: "Diagnostic Devices"

section_number: "876.1400"

section_subject: "Stomach pH electrode."

cfr_reference: "21 CFR 876.1400"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§876.1400 - Stomach pH electrode.