FDA Registration
Active
🇺🇸 United States
AUDICON CORPORATION
Reg #: 3024991168
·
FEI: 3024991168
·
Expires 2026
Products
3
Proprietary Names
5
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- AUDICON CORPORATION
- Registration Number
- 3024991168
- FEI Number
- 3024991168
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3602 Inland Empire, A200
- City
- Ontario
- State
- CA
- ZIP
- 91764
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221052
Owner / Operator
- Firm Name
- Audicon
- Operator Number
- 10086479
- Address
- 3602 Inland Empire, A200
- City
- Ontario
- State
- CA
- Postal Code
- 91764
- Country
- US
- Correspondent
- Lincoln Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2023-09-15 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2023-04-20 |
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | Class 2 | Ear, Nose, Throat | No | 2024-11-21 |
Proprietary Names
Ceretone Fusion Pro, Ceretone Elite
Ceretone Horizon , Ceretone Luma
Ceretone Core One, Ceretone Essential, Ceretone Style, Ceretone Fusion, Ceretone Solid, Ceretone Torch, Ceretone Nexus
Ceretone Core One Pro
Ceretone Beacon,Ceretone Aura
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility