PROXIMA 1 PH MONITOR
Device Facts
| Record ID | K881706 |
|---|---|
| Device Name | PROXIMA 1 PH MONITOR |
| Applicant | Technomanagement, Inc. C/O C.G. |
| Product Code | FFT · Gastroenterology, Urology |
| Decision Date | Jul 12, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1400 |
| Device Class | Class 1 |
Regulatory Classification
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.
