autoSCORE (V 2.0.0)— 510(k) K243743

Substantially Equivalent

Holberg Eeg AS

FDA 510(k) clearance K243743 for autoSCORE (V 2.0.0), Substantially Equivalent on 2025-04-09. Applicant: Holberg Eeg AS. Device class: 2.

Clearance details

Applicant: Holberg Eeg AS
Product code: Code OMB
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2024-12-04
Decision date: 2025-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bergen, NO

Download summary PDF View on FDA.gov ↗

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More clearances from Holberg Eeg AS

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Data sourced from openFDA. This site is unofficial and independent of the FDA.