TONOMITOR(TM)
Device Facts
| Record ID | K870606 |
|---|---|
| Device Name | TONOMITOR(TM) |
| Applicant | Tonometrics Holdings SA C/O Mackeen Consultants |
| Product Code | FFT · Gastroenterology, Urology |
| Decision Date | Apr 10, 1987 |
| 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.
