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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device index-generating electroencephalograph software
Definition Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
Product CodeOLW
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
CORTICAL DYNAMICS LTD
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NEUROWAVE SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1

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