FDA Registration
Active
🇺🇸 United States
Fundus Photo Ophthalmic Imaging System
Reg #: 3007237389
·
FEI: 3007237389
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FUNDUS PHOTO, LLC
- Registration Number
- 3007237389
- FEI Number
- 3007237389
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1240 Dielman Industrial Court
- City
- Saint Louis
- State
- MO
- ZIP
- 63132
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093071
Owner / Operator
- Firm Name
- Fundus Photo, LLC
- Operator Number
- 10027139
- Address
- 1240 Dielman Industrial Court
- City
- Saint Louis
- State
- MO
- Postal Code
- 63132
- Country
- US
- Correspondent
- DALE BRODSKY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2025-03-28 |
Proprietary Names
Fundus Photo Ophthalmic Imaging System
Establishment Types
Manufacture Medical Device