RightEye Vision System— 510(k) K181771
Substantially EquivalentRighteye, LLC
FDA 510(k) clearance K181771 for RightEye Vision System, Substantially Equivalent on 2018-09-28. Applicant: Righteye, LLC. Device class: 2.
Clearance details
- Applicant
- Righteye, LLC
- Product code
- Code GWN
- Device class
- Class 2
- Regulation
- 21 CFR 882.1460
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethesda, MD, US
Recent devices under product code GWN
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