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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| Record | Firm | Date | Builder |
|---|---|---|---|
| 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, LLC | 2013-07-15 |
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Every clearance here is in the API, with alerts when new ones post.