FDA Registration
Active
🇺🇸 United States
Sombra 4S
Reg #: 1044692
·
FEI: 1044692
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Magnatone Hearing Aid Corp. dba Persona Medical
- Registration Number
- 1044692
- FEI Number
- 1044692
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 170 N. Cypress Way
- City
- Casselberry
- State
- FL
- ZIP
- 32707
- Country
- US
Owner / Operator
- Firm Name
- Magnatone Hearing Aid Corp. dba Persona Medical
- Operator Number
- 10023549
- Address
- 170 N. Cypress Way
- City
- Casselberry
- State
- FL
- Postal Code
- 32707
- Country
- US
- Correspondent
- Don E Campbell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2007-11-30 |
Proprietary Names
Sombra 4S
Sombra 8P
Sombra 8S
Evok 927r
Sombra 8R
RX Ear Open Fit
Sombra 4P
Sombra 4R
Evok 920r
Ole' 2125
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device