EXW · Pill, Radio
Gastroenterology, Urology · 21 CFR 876.1725 · Class 2
Overview
| Product Code | EXW |
|---|---|
| Device Name | Pill, Radio |
| Regulation | 21 CFR 876.1725 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K840934 | MEDILOG PH1 | Oxford Medilog, Inc. | Jun 28, 1984 | SESE |
Top Applicants
- Oxford Medilog, Inc. — 1 clearance
