The following data is part of a premarket notification filed by Visionsense Ltd. with the FDA for Vs3 Stereoscopic High Definition Vision System.
| Device ID | K141002 |
| 510k Number | K141002 |
| Device Name: | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM |
| Classification | Arthroscope |
| Applicant | Visionsense Ltd. 57 LAZY BROOK ROAD Monroe, CT 06468 |
| Contact | Raymond Kelly |
| Correspondent | Raymond Kelly Visionsense Ltd. 57 LAZY BROOK ROAD Monroe, CT 06468 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-18 |
| Decision Date | 2014-06-26 |
| Summary: | summary |