FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM
Device Facts
| Record ID | K896288 |
|---|---|
| Device Name | FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM |
| Applicant | Oakfield Instruments, Ltd. |
| Product Code | FFT · Gastroenterology, Urology |
| Decision Date | May 4, 1990 |
| 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.
