The following data is part of a premarket notification filed by Righteye, Llc with the FDA for Righteye Vision System.
| Device ID | K181771 |
| 510k Number | K181771 |
| Device Name: | RightEye Vision System |
| Classification | Nystagmograph |
| Applicant | RightEye, LLC 7979 Old Georgetown Rd., Suite 801 Bethesda, MD 20814 |
| Contact | Adam Gross |
| Correspondent | Adam Gross RightEye, LLC 7979 Old Georgetown Rd., Suite 801 Bethesda, MD 20814 |
| Product Code | GWN |
| CFR Regulation Number | 882.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-03 |
| Decision Date | 2018-09-28 |
| Summary: | summary |