Home / 510(k) Clearances / K231068

510(k) K231068

autoSCORE by Holberg Eeg AS — Product Code OMB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2024
Date Received
April 14, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user

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  • K243743 — autoSCORE (V 2.0.0) (April 9, 2025)
  • K242446 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (January 22, 2025)
  • K241390 — NeuroMatch (November 26, 2024)
  • K240408 — REMI-AI Rapid Detection Module (REMI-AI RDM) (October 17, 2024)
  • K240993 — encevis (2.1) (September 27, 2024)
  • K231779 — REMI AI Discrete Detection Module (January 3, 2024)
  • K222450 — LVIS NeuroMatch (June 9, 2023)