The following data is part of a premarket notification filed by Visionsense, Ltd. with the FDA for Visionsense Stereoscopic Vision System (vs System).
| Device ID | K082667 |
| 510k Number | K082667 |
| Device Name: | VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM) |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| 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 | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-12 |
| Decision Date | 2008-10-30 |
| Summary: | summary |