The following data is part of a premarket notification filed by Barco Nv with the FDA for Nexxis Or.
| Device ID | K122167 |
| 510k Number | K122167 |
| Device Name: | NEXXIS OR |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk, BE 8500 |
| Contact | Lieven De Wandel |
| Correspondent | Lieven De Wandel BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk, BE 8500 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-23 |
| Decision Date | 2013-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334002081 | K122167 | 000 |
| 05415334002074 | K122167 | 000 |
| 05415334002067 | K122167 | 000 |
| 05415334002036 | K122167 | 000 |
| 05415334001787 | K122167 | 000 |
| 05415334001770 | K122167 | 000 |
| 05415334001701 | K122167 | 000 |
| 05415334001664 | K122167 | 000 |
| 05415334001657 | K122167 | 000 |