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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device normalizing quantitative electroencephalograph software
Regulation Description Electroencephalograph.
Definition Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.
Product CodeOLU
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
ELMINDA, LTD
  SUBSTANTIALLY EQUIVALENT 1
G.TEC MEDICAL ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 1
IMEDISYNC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUROFIELD INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2025 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Emotional Changes 1 1
Muscle Weakness 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Pain 1 1

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