FDA Registration
Active
🇺🇸 United States
Polysmith Sleep System, Model NTI7593
Reg #: 1063925
·
FEI: 3002459124
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- NEUROTRONICS, LLC
- Registration Number
- 1063925
- FEI Number
- 3002459124
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 13800 Tech City Circle, Suite 400
- City
- Alachua
- State
- FL
- ZIP
- 32615
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161650
Owner / Operator
- Firm Name
- NEUROTRONICS, LLC
- Operator Number
- 9030449
- Address
- 13800 Tech City Circle, Suite 400, --
- City
- Alachua
- State
- FL
- Postal Code
- 32615
- Country
- US
- Correspondent
- James C Smith
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | Class 2 | Neurology | No | 2017-03-09 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2017-03-09 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2017-03-09 |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | Class 2 | Cardiovascular | No | 2017-03-09 |
Proprietary Names
Polysmith Sleep System, Model NTI7593
Establishment Types
Manufacture Medical Device