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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device computerized cognitive assessment aid for concussion
Regulation Description Computerized cognitive assessment aid for concussion.
Definition For use as an assessment aid in the management of concussion.
Product CodePOM
Regulation Number 882.1471
Device Class 2


Premarket Reviews
ManufacturerDecision
IMPACT APPLICATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SWAY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISTA LIFESCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1

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