| K-number | K213957 |
| Device name | Demetra Dermatoscope BDEM-01 |
| Applicant | Barco N.V. |
| Product code | PSN |
| Device class | Class II |
| Decision date | Mar 11, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 878.4580 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov