The following data is part of a premarket notification filed by Barco Nv with the FDA for Demetra Dermatoscope Bdem-01.
| Device ID | K213957 |
| 510k Number | K213957 |
| Device Name: | Demetra Dermatoscope BDEM-01 |
| Classification | Light Based Imaging |
| Applicant | Barco NV President Kennedypark 35 Kortrijk, BE 8500 |
| Contact | Imke Storm |
| Correspondent | Imke Storm Barco NV President Kennedypark 35 Kortrijk, BE 8500 |
| Product Code | PSN |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-17 |
| Decision Date | 2022-03-11 |