FDA Registration
Active
🇷🇺 Russian Federation
Neuro-IOM system with Neuro-IOM.NET software, models - 32/B - 32/S - 16/S
Reg #: 3006418479
·
FEI: 3006418479
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- NEUROSOFT LTD
- Registration Number
- 3006418479
- FEI Number
- 3006418479
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5 Voronin Street
- City
- Ivanovo Ivanovskaya Oblast'
- Country
- RU
Regulatory Submissions
- 510(k) Number
- K190703
Owner / Operator
- Firm Name
- Neurosoft LTD
- Operator Number
- 10035792
- Address
- 5 Voronin Street
- City
- Ivanovo
- State
- Ivanovskaya Oblast'
- Postal Code
- 153032
- Country
- RU
- Correspondent
- Mikhail U Durdin
US Agent
- Business Name
- TeleEMG, LLC
- Contact Name
- Joe F Jabre
- Address
- 7304 Beverly Blvd #357
- City
- Los Angeles
- State
- CA
- ZIP
- 90036
- Country
- US
- [email protected]
- Phone
- 617 8403253
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2021-05-28 |
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2021-05-28 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2021-05-28 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2021-05-28 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2021-05-28 |
Proprietary Names
Neuro-IOM system with Neuro-IOM.NET software, models - 32/B - 32/S - 16/S
Neuro-IOM
Establishment Types
Manufacture Medical Device