FDA Registration
Active
🇦🇹 Austria
cortiQ PRO
Reg #: 3008008477
·
FEI: 3008008477
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- G.TEC MEDICAL ENGINEERING GMBH
- Registration Number
- 3008008477
- FEI Number
- 3008008477
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Herbersteinstrasse 60
- City
- Graz Steiermark
- Country
- AT
Regulatory Submissions
- 510(k) Number
- K191432
Owner / Operator
- Firm Name
- G.TEC MEDICAL ENGINEERING GMBH
- Operator Number
- 9084852
- Address
- 14 SIERNINGSTRASSE, --
- City
- SCHIEDLBERG
- State
- AT-NOTA
- Postal Code
- 4521
- Country
- AT
- Correspondent
- CHRISTOPH - GUGER
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2020-03-05 |
| Amplifier, Physiological Signal | GWL | Class 2 | Neurology | No | 2020-03-05 |
| Normalizing Quantitative Electroencephalograph Software | OLU | Class 2 | Neurology | No | 2020-03-05 |
Proprietary Names
cortiQ PRO
Establishment Types
Manufacture Medical Device