Atlas FDA

NCG

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1440
Medical specialty
Neurology
FDA definition
Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis."
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RecordFirmDateBuilder
Ceribell Delirium Monitor System (K251936)Ceribell, Inc.2025-12-08+ Add
DeltaScan Monitor (K222680)Prolira B.V.2023-02-02+ Add
NEBA SYSTEM (DEN110019)Lexicor Medical Technology, LLC2013-07-15

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Every clearance here is in the API, with alerts when new ones post.