The following data is part of a premarket notification filed by Rota Systems Medfurniture, Inc. with the FDA for Rota System Xl.
| Device ID | K931839 |
| 510k Number | K931839 |
| Device Name: | ROTA SYSTEM XL |
| Classification | Stand, Instrument, Ac-powered, Ophthalmic |
| Applicant | ROTA SYSTEMS MEDFURNITURE, INC. 519 N. BUCKNER P.O. BOX 361 Derby, KS 67037 |
| Contact | Sam R Myers |
| Correspondent | Sam R Myers ROTA SYSTEMS MEDFURNITURE, INC. 519 N. BUCKNER P.O. BOX 361 Derby, KS 67037 |
| Product Code | HMF |
| CFR Regulation Number | 886.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-13 |
| Decision Date | 1993-11-22 |