POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
Device Facts
| Record ID | K010130 |
|---|---|
| Device Name | POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103 |
| Applicant | Medtronic Functional Diagnostics A/S |
| Product Code | FFX · Gastroenterology, Urology |
| Decision Date | Feb 7, 2001 |
| Decision | SESE |
| Submission Type | Special |
| 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.
