| Device |
physiological signal based seizure monitoring system |
| Regulation Description |
Non-electroencephalogram (EEG) physiological signal based seizure monitoring system. |
| Definition |
The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device. |
| Physical State |
The device should contain a part that collects physiological signals (usually attached to the human body) and a base station that provides information to the caregiver or healthcare professionals. |
| Technical Method |
Physiological signal measurement and analysis |
| Target Area |
Human body surface areas |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Neurology |
|---|
| Product Code | POS |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.1580
|
|---|
| 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 |
