RightEye Vision System
510(k)K181771NeurologyGWN
RightEye, LLC is listed for RightEye Vision System (K181771). The FDA list gives September 28, 2018 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is GWN. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K181771
- Date of final decision
- September 28, 2018
- Company on the FDA list
- RightEye, LLC
- Lead panel
- Neurology
- Primary product code
- GWN
- openFDA device name for the code
- Nystagmograph
- Device class
- 2
- Regulation number
- 882.1460
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary