The following data is part of a premarket notification filed by Medicor Usa Ltd. with the FDA for Urolix-3 Urological Table.
| Device ID | K840227 |
| 510k Number | K840227 |
| Device Name: | UROLIX-3 UROLOGICAL TABLE |
| Classification | Table, Radiographic, Tilting |
| Applicant | MEDICOR USA LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-19 |
| Decision Date | 1984-03-23 |