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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
CORSCIENCE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

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