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."
| Device Type ID | 3745 |
| Device Name | Neuropsychiatric Interpretative Electroencephalograph Assessment Aid |
| Physical State | Software |
| Technical Method | Software Analysis Of EEG Signals |
| Target Area | Software |
| Regulation Description | Neuropsychiatric Interpretive Electroencephalograph Assessment Aid. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1440 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NCG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3745 |
| Device | Neuropsychiatric Interpretative Electroencephalograph Assessment Aid |
| Product Code | NCG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Neuropsychiatric Interpretive Electroencephalograph Assessment Aid. |
| CFR Regulation Number | 882.1440 [🔎] |