The following data is part of a premarket notification filed by Barco Nv with the FDA for Demetra Bdem-01 Dermatoscope.
| Device ID | K192829 |
| 510k Number | K192829 |
| Device Name: | Demetra BDEM-01 Dermatoscope |
| Classification | Light Based Imaging |
| Applicant | Barco NV President Kennedypark 35 Kortrijk, BE 8500 |
| Contact | Julie Vandecandelaere |
| Correspondent | Julie Vandecandelaere Barco NV President Kennedypark 35 Kortrijk, BE 8500 |
| Product Code | PSN |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-02 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334001763 | K192829 | 000 |