FDA Registration
Active
🇺🇸 United States
Astraguard, Filtrette, Filtrette A Bacterial Viral Filters
Reg #: 1220253
·
FEI: 1220253
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SDI DIAGNOSTICS, INC.
- Registration Number
- 1220253
- FEI Number
- 1220253
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10 Hampden Dr
- City
- South Easton
- State
- MA
- ZIP
- 02375
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062913
Owner / Operator
- Firm Name
- SDI DIAGNOSTICS, INC
- Operator Number
- 1220253
- Address
- 10 HAMPDEN DR., --
- City
- South Easton
- State
- MA
- Postal Code
- 02375
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2012-04-13 |
Proprietary Names
Astraguard, Filtrette, Filtrette A Bacterial Viral Filters
Establishment Types
Manufacture Medical Device