FDA Registration
Active
🇺🇸 United States
Cognision
Reg #: 3011184129
·
FEI: 3011184129
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- NEURONETRIX SOLUTIONS, LLC
- Registration Number
- 3011184129
- FEI Number
- 3011184129
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1044 E Chestnut St Ste 8
- City
- Louisville
- State
- KY
- ZIP
- 40204
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141316
Owner / Operator
- Firm Name
- Neuronetrix Solutions, LLC
- Operator Number
- 10048856
- Address
- 1044 E Chestnut Street, Suite 8
- City
- Louisville
- State
- KY
- Postal Code
- 40204
- Country
- US
- Correspondent
- Kalford Fadem
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2015-03-11 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2015-03-11 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2015-03-11 |
Proprietary Names
Cognision
Establishment Types
Manufacture Medical Device