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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


Premarket Reviews
ManufacturerDecision
BRAIN SENTINEL, INC.
  SUBSTANTIALLY EQUIVALENT 2
EMPATICA SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Alarm 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Convulsion/Seizure 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 EMPATICA SRL II Oct-24-2023
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