Data / Medical devices / Norway / Holberg Eeg AS
Holberg Eeg AS: FDA-registered device maker in Bergen Hordaland, Norway, 2 510(k) clearances
Holberg Eeg AS is registered with the FDA (registration 3030646118) in Bergen Hordaland, Norway. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 9, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030646118
- Address
- Fjosangerveien 70 A 5068 Bergen, Bergen Hordaland, Norway, 5068
- Owner or operator
- Holberg EEG AS (10090411)
- Roles
- Manufacturer
- First device listed
- March 25, 2024
- Registered through
- 2026
- Brand names listed
- autoSCORE, autoSCORE (V 2)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automatic Event Detection Software For Full-Montage Electroencephalograph | OMB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 9, 2025 | K243743 | autoSCORE (V 2.0.0) | OMB | Substantially Equivalent | Holberg Eeg AS | accessdata.fda.gov |
| January 7, 2024 | K231068 | autoSCORE | OMB | Substantially Equivalent | Holberg Eeg AS | accessdata.fda.gov |
Compare with other makers
Updated April 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.