FDA Registration
Active
🇺🇸 United States
NEUROONE MEDICAL TECHNOLOGIES CORP.
Reg #: 3016438686
·
FEI: 3016438686
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- NEUROONE MEDICAL TECHNOLOGIES CORP.
- Registration Number
- 3016438686
- FEI Number
- 3016438686
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7599 Anagram Drive
- City
- Eden Prairie
- State
- MN
- ZIP
- 55344
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231675
Owner / Operator
- Firm Name
- NeuroOne Medical Technologies Corp.
- Operator Number
- 10062284
- Address
- 7599 Anagram Drive
- City
- Eden Prairie
- State
- MN
- Postal Code
- 55344
- Country
- US
- Correspondent
- Evan Goulet
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2024-11-07 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2024-11-07 |
| Electrode, Cortical | GYC | Class 2 | Neurology | No | 2020-01-08 |
| Electrode, Depth | GZL | Class 2 | Neurology | No | 2025-02-04 |
Proprietary Names
OneRF Ablation System
EVO sEEG System
OneRF Trigeminal Nerve Radiofrequency Probes
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198