The following data is part of a premarket notification filed by Medicor Usa Ltd. with the FDA for Floor Mounted X-ray Tubestand.
| Device ID | K843335 |
| 510k Number | K843335 |
| Device Name: | FLOOR MOUNTED X-RAY TUBESTAND |
| Classification | Tube Mount, X-ray, Diagnostic |
| 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 | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-27 |
| Decision Date | 1984-11-27 |