Subpart C—Monitoring Devices
FDA submissions for Subpart C—Monitoring Devices in the Gastroenterology, Urology (GU) review panel, including product codes and regulations.
Section range: §§ 876.2040–876.2100
CFR Part: 876
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| KPN | Alarm, Conditioned Response Enuresis | 876.2040 | 2 | 37 |
| OQT | Prostate Lesion, Documentation, System | 876.2050 | 2 | 1 |
| QEF | Pressure Ulcer Management Tool | 876.2100 | 1 | 1 |