FDA Registration
Active
🇺🇸 United States
Cochlear Osia® System
Reg #: 3005900820
·
FEI: 3005900820
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- COCHLEAR AMERICAS
- Registration Number
- 3005900820
- FEI Number
- 3005900820
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10350 Park Meadows Drive
- City
- Lone Tree
- State
- CO
- ZIP
- 80124
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231204
Owner / Operator
- Firm Name
- COCHLEAR AMERICAS
- Operator Number
- 9076254
- Address
- 10350 Park Meadows Drive
- City
- Lone Tree
- State
- CO
- Postal Code
- 80124
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Active Implantable Bone Conduction Hearing System | PFO | Class 2 | Ear, Nose, Throat | No | 2023-08-29 |
Proprietary Names
Cochlear Osia® System
Establishment Types
Complaint File Establishment per 21 CFR 820.198