FDA Registration
Active
🇺🇸 United States
Spect Ophthalmic Camera
Reg #: 3015236232
·
FEI: 3015236232
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- SPECT INC
- Registration Number
- 3015236232
- FEI Number
- 3015236232
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 48 S Rio Grande St
- City
- Salt Lake City
- State
- UT
- ZIP
- 84101
- Country
- US
Owner / Operator
- Firm Name
- Spect Inc
- Operator Number
- 10059620
- Address
- 455b Portage Ave
- City
- Palo Alto
- State
- CA
- Postal Code
- 94306
- Country
- US
- Correspondent
- Michael Ricci
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Ophthalmic, General-Use | PJZ | Class 2 | Ophthalmic | No | 2019-02-04 |
Proprietary Names
Spect Ophthalmic Camera
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198