FDA Registration
Active
🇮🇱 Israel
Neuro Omega system
Reg #: 9615126
·
FEI: 3001610756
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- ALPHA OMEGA ENGINEERING LTD.
- Registration Number
- 9615126
- FEI Number
- 3001610756
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Hamerkava St. 6, Tsiporit Industrial Zone
- City
- Nof HaGalil Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K220553
Owner / Operator
- Firm Name
- ALPHA OMEGA ENGINEERING LTD.
- Operator Number
- 9039414
- Address
- Hamerkava st.6, Tsiporit Industrial Zone
- City
- Nof HaGalil (Nazareth Illit)
- State
- Northern
- Postal Code
- 1789062
- Country
- IL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Depth | GZL | Class 2 | Neurology | No | 2022-12-06 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2022-12-06 |
| Electrode, Cortical | GYC | Class 2 | Neurology | No | 2022-12-06 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2022-12-06 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2022-12-06 |
Proprietary Names
Neuro Omega system
NeuroSmart system
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device