FDA Registration
Active
🇺🇸 United States
NeuroSENSE Monitoring System, Model NS-901, with EasyPrep Electrodes EK-901
Reg #: 3008657519
·
FEI: 3008657519
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- NEUROWAVE SYSTEMS INC.
- Registration Number
- 3008657519
- FEI Number
- 3008657519
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 25825 Science Park, STE 250
- City
- Beachwood
- State
- OH
- ZIP
- 44122
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202621
Owner / Operator
- Firm Name
- NeuroWave Systems Inc.
- Operator Number
- 10033810
- Address
- 25825 Science Park, STE 250
- City
- Beachwood
- State
- OH
- Postal Code
- 44122
- Country
- US
- Correspondent
- Tatjana Zikov
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Index-Generating Electroencephalograph Software | OLW | Class 2 | Neurology | No | 2022-11-21 |
| Burst Suppression Detection Software For Electroencephalograph | ORT | Class 2 | Neurology | No | 2022-11-21 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2022-11-21 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2022-11-21 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2022-11-21 |
Proprietary Names
NeuroSENSE Monitoring System, Model NS-901, with EasyPrep Electrodes EK-901
Establishment Types
Manufacture Medical Device