FDA Registration
Active
🇮🇱 Israel
Neuro Omega
Reg #: 9615126
·
FEI: 3001610756
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
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
- K123796
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 |
|---|---|---|---|---|---|
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2013-05-23 |
| Electrode, Depth | GZL | Class 2 | Neurology | No | 2013-05-23 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2013-05-23 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2013-05-23 |
Proprietary Names
Neuro Omega
Establishment Types
Manufacture Medical Device