AMBULATORY PH DATA RECORDER SYSTEM, APH-2000
Device Facts
| Record ID | K882551 |
|---|---|
| Device Name | AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 |
| Applicant | Intl. Biomedics, Inc. |
| Product Code | KLA · Gastroenterology, Urology |
| Decision Date | Oct 12, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1725 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.
