The following data is part of a premarket notification filed by Barco Nv with the FDA for Barcomed 5mp1h.
| Device ID | K000014 |
| 510k Number | K000014 |
| Device Name: | BARCOMED 5MP1H |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCO NV P.O. BOX 12038 La Jolla, CA 92039 -2038 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson BARCO NV P.O. BOX 12038 La Jolla, CA 92039 -2038 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-03 |
| Decision Date | 2000-03-14 |