The following data is part of a premarket notification filed by Barco with the FDA for Mdng-3220 (nio 3mp Led).
| Device ID | K150821 |
| 510k Number | K150821 |
| Device Name: | MDNG-3220 (Nio 3MP LED) |
| Classification | Display, Diagnostic Radiology |
| Applicant | Barco President Kennedypark 35 Kortrijk, BE 8500 |
| Contact | Lieven De Wandel |
| Correspondent | Lieven De Wandel Barco President Kennedypark 35 Kortrijk, BE 8500 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-27 |
| Decision Date | 2015-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334000360 | K150821 | 000 |
| 05415334000353 | K150821 | 000 |
| 05415334000346 | K150821 | 000 |
| 05415334000339 | K150821 | 000 |