The following data is part of a premarket notification filed by Barco Nv with the FDA for Demetra Analytics Toolkit.
| Device ID | K201408 |
| 510k Number | K201408 |
| Device Name: | Demetra Analytics Toolkit |
| 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 | 2020-05-28 |
| Decision Date | 2021-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334036192 | K201408 | 000 |