FDA Registration
Active
🇺🇸 United States
HD75
Reg #: 3011196525
·
FEI: 3011196525
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- NANTSOUND, INC.
- Registration Number
- 3011196525
- FEI Number
- 3011196525
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 960 N Northwest Hwy
- City
- Park Ridge
- State
- IL
- ZIP
- 60068
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212609
Owner / Operator
- Firm Name
- NantSound, Inc.
- Operator Number
- 10047819
- Address
- 960 N Northwest Hwy
- City
- Park Ridge
- State
- IL
- Postal Code
- 60068
- Country
- US
- Correspondent
- Cynthia A Kaempfer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Self-Fitting Air-Conduction Hearing Aid, Prescription | QDD | Class 2 | Ear, Nose, Throat | No | 2024-06-06 |
Proprietary Names
HD75
Sound World Solutions
HD75R
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility