| Device |
automatic event detection software for full-montage electroencephalograph |
| Regulation Description |
Electroencephalograph. |
| Definition |
Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user |
| Physical State |
Electroencephalograph analysis software. Does NOT include electrodes, electroencephalograph hardware, basic electroencephalograph software (e.g. used to display, store, archive, or manually annotate data), or automatic event detection software used as an intermediary step in source-localization analysis. |
| Technical Method |
Uses software algorithms to analyze full-montage electroencephalograph (16 electrodes) at user-specified locations and automatically identify areas of interest. |
| Target Area |
Brain |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | OMB |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.1400
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
