| Device Type ID | 3649 |
| Device Name | Analyzer, Spectrum, Electroencephalogram Signal |
| Regulation Description | Electroencephalogram (EEG) Signal Spectrum Analyzer. |
| 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 | 882.1420 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GWS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3649 |
| Device | Analyzer, Spectrum, Electroencephalogram Signal |
| Product Code | GWS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Electroencephalogram (EEG) Signal Spectrum Analyzer. |
| CFR Regulation Number | 882.1420 [🔎] |
| Device Problems | |
|---|---|
High Readings | 1 |
| Total Device Problems | 1 |