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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device 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.
Product CodePOS
Regulation Number 882.1580
Device Class 2