The following data is part of a premarket notification filed by Barco Nv with the FDA for Mdpc-8127.
| Device ID | K203364 |
| 510k Number | K203364 |
| Device Name: | MDPC-8127 |
| Classification | Whole Slide Imaging System |
| Applicant | Barco NV President Kennedypark 35 Kortrijk, BE 8500 |
| Contact | Lieven De Wandel |
| Correspondent | Lieven De Wandel Barco NV President Kennedypark 35 Kortrijk, BE 8500 |
| Product Code | PSY |
| CFR Regulation Number | 864.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-16 |
| Decision Date | 2021-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334001732 | K203364 | 000 |
| 05415334033603 | K203364 | 000 |
| 05415334033665 | K203364 | 000 |
| 05415334044371 | K203364 | 000 |
| 05415334044289 | K203364 | 000 |