[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.1400]

[Page 347]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                      Subpart B--Diagnostic Devices
 
Sec. 876.1400  Stomach pH electrode.

    (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]