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 |
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
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 |