FDA Registration
Active
🇺🇸 United States
Tinnitus Sound Generator Module
Reg #: 2182204
·
FEI: 2182204
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GN Hearing Care Corporation
- Registration Number
- 2182204
- FEI Number
- 2182204
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 8001 E Bloomington Freeway
- City
- BLOOMINGTON
- State
- MN
- ZIP
- 55420
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110932
Owner / Operator
- Firm Name
- GN Hearing A/S
- Operator Number
- 2182204
- Address
- Lautrupbjerg 7
- City
- Ballerup
- State
- Hovedstaden
- Postal Code
- 2750
- Country
- DK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Masker, Tinnitus | KLW | Class 2 | Ear, Nose, Throat | No | 2011-11-22 |
Proprietary Names
Tinnitus Sound Generator Module
Establishment Types
Repack or Relabel Medical Device