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U.S. Department of Health and Human Services

Product Classification

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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 CodePOS
Premarket Review 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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible