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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device brain injury adjunctive interpretive electroencephalograph assessment aid
Definition A prescription device that uses a patient¿s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient¿s brain in the setting of trauma. The Brain Injury Adjunctive Interpretive EEG Assessment Aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.
Product CodePIW
Regulation Number 882.1450
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAINSCOPE COMPANY INC
  SUBSTANTIALLY EQUIVALENT 1
BRAINSCOPE COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 3
BRAINSCOPE COMPANY, INC
  GRANTED 1
BRAINSCOPE COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 2

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