FDA Registration
Active
🇺🇸 United States
Easy LE Adapter (Bernafon)
Reg #: 3015349895
·
FEI: 3015349895
·
Expires 2025
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SBO Hearing Inc.
- Registration Number
- 3015349895
- FEI Number
- 3015349895
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 580 Howard Avenue NJ
- City
- Somerset
- State
- NJ
- ZIP
- 08873
- Country
- US
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 |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2004-04-12 |
Proprietary Names
Easy LE Adapter (Bernafon)
Oticon Own SI (SBO Hearing)
Neutral Charger Plus MNR T R (SBO Hearing)
Oticon SmartCharger miniRITE R (SBO Hearing)
CROS MNR TR (Bernafon)
EarQ F (SBO Hearing)
Bernafon Oasisnxt (SBO Hearing)
AGXO B (SBO Hearing)
Neutral Oasisnxt Custom (SBO Hearing)
Bernafon Encanta (SBO Hearing)
SmartCharger miniRITE R (SBO Hearing)
Neutral Charger Plus MNB T R (SBO Hearing)
BERNAFON
Philips HearSuite (SBO Hearing)
AGXO F (SBO Hearing)
SONIC
AudigyFit 2 (SBO Hearing)
OTICON
Bernafon Entra B (SBO Hearing)
Oticon SmartCharger miniBTE R (SBO Hearing)
SmartCharger miniBTE R (SBO Hearing)
Oticon Genie 2 (SBO Hearing)
Philips HearLink 50 (SBO Hearing)
Establishment Types
Repack or Relabel Medical Device