The following data is part of a premarket notification filed by Visionsense, Ltd. with the FDA for Visionsense Stereoscopic Vision System.
| Device ID | K082355 |
| 510k Number | K082355 |
| Device Name: | VISIONSENSE STEREOSCOPIC VISION SYSTEM |
| Classification | Arthroscope |
| Applicant | VISIONSENSE, LTD. 555 13TH STREET, NW Washington, DC 20004 |
| Contact | Gerard J Prud'homme |
| Correspondent | Gerard J Prud'homme VISIONSENSE, LTD. 555 13TH STREET, NW Washington, DC 20004 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-15 |
| Decision Date | 2008-12-15 |
| Summary: | summary |