NCG — Neuropsychiatric Interpretative Electroencephalograph Assessment Aid Class II
FDA product code NCG covers "Neuropsychiatric Interpretative Electroencephalograph Assessment Aid", a Class II medical device regulated under 21 CFR 882.1440. Submissions are reviewed by the Neurology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NCG
- Device Class
- Class II
- Regulation Number
- 882.1440
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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."