FDA Registration
Active
🇺🇸 United States
AT235
Reg #: 2113281
·
FEI: 2113281
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DIAGNOSTIC GROUP LLC
- Registration Number
- 2113281
- FEI Number
- 2113281
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 10395 W 70th St
- City
- EDEN PRAIRIE
- State
- MN
- ZIP
- 55344
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151616
Owner / Operator
- Firm Name
- DEMANT A/S
- Operator Number
- 8010048
- Address
- KONGEBAKKEN 9, --
- City
- SMORUM
- State
- DK-NOTA
- Postal Code
- DK-2765
- Country
- DK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tester, Auditory Impedance | ETY | Class 2 | Ear, Nose, Throat | No | 2015-12-14 |
Proprietary Names
AT235
Establishment Types
Repack or Relabel Medical Device