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 |