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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device amplitude-integrated electroencephalograph
Regulation Description Electroencephalograph.
Definition Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
Product CodeOMA
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2

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