NCG
- Product code
- NCG
- Device name
- Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1440
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
FDA classification 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."
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251936 | 2025-12-08 | Ceribell, Inc. | Ceribell Delirium Monitor System |
Official FDA classification page: NCG
Classification and pathway per current FDA publications. Data from openFDA (CC0).