The following data is part of a premarket notification filed by Medicor Usa Ltd. with the FDA for Model Rs-3i Radiographic/fluroscopic X-ray System.
| Device ID | K861994 |
| 510k Number | K861994 |
| Device Name: | MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | MEDICOR USA LTD. 1400 HOLLY AVE. Columbus, OH 43212 |
| Contact | Geza Pataky |
| Correspondent | Geza Pataky MEDICOR USA LTD. 1400 HOLLY AVE. Columbus, OH 43212 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-23 |
| Decision Date | 1986-07-18 |