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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neuropsychiatric interpretative electroencephalograph assessment aid
Regulation Description Neuropsychiatric interpretive electroencephalograph assessment aid.
Definition Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis."
Product CodeNCG
Regulation Number 882.1440
Device Class 2


Premarket Reviews
ManufacturerDecision
CERIBELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROLIRA B.V.
  SUBSTANTIALLY EQUIVALENT 1

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