Physiological Signal Based Seizure Monitoring System
POS · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1580
Classification
FDA Product Code
POS
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.1580
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.