The following data is part of a premarket notification filed by Visionsearch Pty Ltd with the FDA for Visionsearch 1.
| Device ID | K120104 |
| 510k Number | K120104 |
| Device Name: | VISIONSEARCH 1 |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | VISIONSEARCH PTY LTD 460 PACIFIC HIGHWAY SUITE 408 St Leonards, AU 2074 |
| Contact | Arthur Brandwood |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-01-13 |
| Decision Date | 2012-05-21 |
| Summary: | summary |