FDA 510(k)

autoSCORE（V 2.0.0）

K号: K243743 · 2025-04-09

决定日期2025-04-09

产品代码OMB

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决定实质等同

器械摘要

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

常见问题

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. The listed applicant is Holberg Eeg AS. The 510(k) number is K243743.

When did autoSCORE (V 2.0.0) receive FDA 510(k) clearance?

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

Who is the listed applicant for autoSCORE (V 2.0.0)?

The FDA 510(k) record lists Holberg Eeg AS as the applicant. This does not by itself establish the device manufacturer.

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

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

列明Holberg Eeg AS为申报人的其他记录

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