510(k) Report

FDA applicant

Holberg Eeg AS

Bergen, NO2 decisions2024–20250 recalls

FDA records 2 decisions for Holberg Eeg AS (Bergen, NO) from 2024 to 2025: 2 510(k) clearances. All are in product code OMB (Automatic Event Detection Software For…). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Holberg Eeg AS’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024: 12025: 1
2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Holberg Eeg AS by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Holberg Eeg AS’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K243743autoSCORE (V 2.0.0)Holberg Eeg AS · 20251cites it
  • K231068autoSCOREHolberg Eeg AS · 20241cites it

What has FDA decided for it lately?

  • K243743autoSCORE (V 2.0.0)Holberg Eeg AS · 2025
  • K231068autoSCOREHolberg Eeg AS · 2024

All 2 as Holberg Eeg AS →