Definition: Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
| Device Type ID | 3765 |
| Device Name | Non-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 A Database (normal Or Otherwise) Or Electroencephalograph Software Th |
| Technical Method | Uses Software Algorithms As A Tool To Analyze Electroencephalograph (from User-specified Electrode Number And Locations) And Automatically Calculate Conventional Electroencephalograph Parameters. (e.g. Spectral Edge Frequency, Total Power, Percent Al |
| 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 | OLT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3765 |
| Device | Non-normalizing Quantitative Electroencephalograph Software |
| Product Code | OLT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electroencephalograph. |
| CFR Regulation Number | 882.1400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EB NEURO, S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KVIKNA EHF | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEURONETRIX SOLUTIONS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUROSOFT LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUROWAVE SYSTEMS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Smoking | 3 |
Appropriate Term/Code Not Available | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Device Stops Intermittently | 1 |
Device Operates Differently Than Expected | 1 |
Mechanical Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Temperature Problem | 1 |
| Total Device Problems | 11 |