Definition: Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database For Interpretation By A Qualified User.
| Device Type ID | 3766 |
| Device Name | Normalizing Quantitative Electroencephalograph Software |
| Physical State | Electroencephalograph Analysis Software. Does NOT Include Electrodes, Amplitude-integrated Electroencephalograph, Automatic Event-detection Software, Software That Compares Data To Non-normative Databases, Software That Does Not Compare To A Normativ |
| Technical Method | Uses Software Algorithms As A Tool To Analyze Electroencephalograph (from User-specified Electrode Number And Locations) And Automatically Calculates Conventional Electroencephalograph Parameters. (e.g. Power, Asymmetry, Coherence) And Normalizes The |
| Target Area | Brain |
| Regulation Description | Electroencephalograph. |
| 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 | 882.1400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OLU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3766 |
| Device | Normalizing Quantitative Electroencephalograph Software |
| Product Code | OLU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electroencephalograph. |
| CFR Regulation Number | 882.1400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BRAINMASTER TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EIMINDA LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |