| Device |
automatic event detection software for polysomnograph with electroencephalograph |
| Regulation Description |
Electroencephalograph. |
| Definition |
Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user |
| Physical State |
Electroencephalograph analysis software. Does NOT include electrodes, electroencephalograph hardware, polysomnograph hardware, or basic electroencephalograph/polysomnograph software (e.g. used to display, store, archive, or manually annotate data). |
| Technical Method |
Uses software algorithms to analyze electroencephalograph and polysomnograph waveforms and automatically identify areas of interest to the user |
| Target Area |
Brain |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | OLZ |
|---|
| Premarket Review |
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
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 |
|
|
