The following data is part of a premarket notification filed by Barco Nv Barcoview with the FDA for Nio 3mp Medical Flat Panel Display System.
| Device ID | K042661 |
| 510k Number | K042661 |
| Device Name: | NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCO NV BARCOVIEW 12200 ACADEMY ROAD NE # 931 Albuquerque, NM 87111 |
| Contact | Frank Furguson |
| Correspondent | Frank Furguson BARCO NV BARCOVIEW 12200 ACADEMY ROAD NE # 931 Albuquerque, NM 87111 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-28 |
| Decision Date | 2004-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415334001442 | K042661 | 000 |
| 05415334001435 | K042661 | 000 |