Part 878 Subpart B—Diagnostic Devices
FDA submissions for Part 878 Subpart B—Diagnostic Devices in the General, Plastic Surgery (SU) review panel, including product codes and regulations.
Section range: §§ 878.1800–878.1820
CFR Part: 878
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| EPY | Speculum, Ent | 878.1800 | 1 | 12 |
| FXE | Speculum, Non-Illuminated | 878.1800 | 1 | 0 |
| FXF | Speculum, Illuminated | 878.1800 | 1 | 1 |
| FXG | Specula Accessories | 878.1800 | 1 | 1 |
| JYK | Holder, Ear Speculum | 878.1800 | 1 | 1 |
| KAG | Holder, Speculum, Ent | 878.1800 | 1 | 2 |
| ONV | Electrical Impedance Spectrometer | 878.1820 | 2 | 1 |
| OYD | Optical Diagnostic Device For Melanoma Detection | 878.1820 | 2 | 1 |
