FDA Registration
Active
🇳🇴 Norway
autoSCORE
Reg #: 3030646118
·
FEI: 3030646118
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HOLBERG EEG AS
- Registration Number
- 3030646118
- FEI Number
- 3030646118
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Fjosangerveien 70 A, 5068 Bergen
- City
- Bergen Hordaland
- Country
- NO
Regulatory Submissions
- 510(k) Number
- K231068
Owner / Operator
- Firm Name
- Holberg EEG AS
- Operator Number
- 10090411
- Address
- Fjosangerveien 70 A, 5068 Bergen
- City
- Bergen
- State
- NO-NOTA
- Postal Code
- 5068
- Country
- NO
- Correspondent
- Smriti Franklin
US Agent
- Business Name
- Natus Middleton
- Contact Name
- Douwe VanDenBrink
- Address
- 3150 Pleasant View Road, Middleton
- City
- Middleton
- State
- WI
- ZIP
- 53562
- Country
- US
- [email protected]
- Phone
- 608 8298500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automatic Event Detection Software For Full-Montage Electroencephalograph | OMB | Class 2 | Neurology | No | 2024-03-25 |
Proprietary Names
autoSCORE
Establishment Types
Manufacture Medical Device