The following data is part of a premarket notification filed by Barco Nv with the FDA for Nio Color 3mp Led.
Device ID | K131295 |
510k Number | K131295 |
Device Name: | NIO COLOR 3MP LED |
Classification | System, Image Processing, Radiological |
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 | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-06 |
Decision Date | 2013-05-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05415334001121 | K131295 | 000 |
05415334001114 | K131295 | 000 |
05415334001107 | K131295 | 000 |