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FDA 510(k)

autoSCORE (V 2.0.0)

K-Number: K243743 · 2025-04-09

ApplicantHolberg Eeg AS
Decision Date2025-04-09
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

autoSCORE (V 2.0.0) is a medical device manufactured by Holberg Eeg AS. It received FDA 510(k) clearance on 2025-04-09 under approval number K243743. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the autoSCORE (V 2.0.0)?

autoSCORE (V 2.0.0) is a medical device that received FDA 510(k) clearance on 2025-04-09. It is manufactured by Holberg Eeg AS. The 510(k) number is K243743.

When was autoSCORE (V 2.0.0) approved by the FDA?

autoSCORE (V 2.0.0) received FDA 510(k) clearance on 2025-04-09, under approval number K243743.

What company makes autoSCORE (V 2.0.0)?

autoSCORE (V 2.0.0) is manufactured by Holberg Eeg AS.

What is the FDA product code for autoSCORE (V 2.0.0)?

The FDA product code for autoSCORE (V 2.0.0) is OMB.

Other Devices by Holberg Eeg AS

K231068autoSCORE

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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