FDA Registration
Active
🇺🇸 United States
RightEye Vision System
Reg #: 3015176873
·
FEI: 3015176873
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- RIGHTEYE, LLC
- Registration Number
- 3015176873
- FEI Number
- 3015176873
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6710A Rockledge Drive, Suite 400
- City
- Bethesda
- State
- MD
- ZIP
- 20817
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181771
Owner / Operator
- Firm Name
- RightEye, LLC
- Operator Number
- 10058824
- Address
- 6710A Rockledge Drive, Suite 400
- City
- Bethesda
- State
- MD
- Postal Code
- 20817
- Country
- US
- Correspondent
- Adam Gross
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nystagmograph | GWN | Class 2 | Neurology | No | 2018-10-31 |
Proprietary Names
RightEye Vision System
Establishment Types
Manufacture Medical Device