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 | K131434 |
| 510k Number | K131434 |
| Device Name: | VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM |
| Classification | Endoscope, Neurological |
| 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 | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-17 |
| Decision Date | 2013-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18130400103694 | K131434 | 000 |
| 10813040013100 | K131434 | 000 |
| 10813040013094 | K131434 | 000 |
| 10813040013377 | K131434 | 000 |
| 18130400103014 | K131434 | 000 |
| 18130400103045 | K131434 | 000 |
| 18130400103052 | K131434 | 000 |
| 18130400103199 | K131434 | 000 |
| 18130400103212 | K131434 | 000 |
| 18130400103373 | K131434 | 000 |
| 18130400103397 | K131434 | 000 |
| 10884521833173 | K131434 | 000 |