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
| Device Type ID | 3793 |
| Device Name | Physiological Signal Based Seizure Monitoring System |
| 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 Description | Non-electroencephalogram (EEG) Physiological Signal Based Seizure Monitoring System. |
| 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 | 882.1580 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | POS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3793 |
| Device | Physiological Signal Based Seizure Monitoring System |
| Product Code | POS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Non-electroencephalogram (EEG) Physiological Signal Based Seizure Monitoring System. |
| CFR Regulation Number | 882.1580 [🔎] |