FDA Registration
Active
🇺🇸 United States
Opticare AI FD16 Fundus Camera
Reg #: 3029786007
·
FEI: 3029786007
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- OPTICARE INC
- Registration Number
- 3029786007
- FEI Number
- 3029786007
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7513 Se 27th St Ste A
- City
- Mercer Island
- State
- WA
- ZIP
- 98040
- Country
- US
Owner / Operator
- Firm Name
- Opticare Inc
- Operator Number
- 10089058
- Address
- 7513 SE 27th ST, Suite A
- City
- Mercer Island
- State
- WA
- Postal Code
- 98040
- Country
- US
- Correspondent
- Yaqin He
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Ophthalmic, General-Use | PJZ | Class 2 | Ophthalmic | No | 2023-11-02 |
Proprietary Names
Opticare AI FD16 Fundus Camera
Opticare AI Fundus Camera
Opticare FD16 Fundus Camera
Opticare Fundus Camera
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device