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510(k) DEN150037

ImPACT Computerized Neurocognitive Concussion Management Aid by Impact Applications, Inc. — Product Code POM

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: August 22, 2016
Date Received: August 11, 2015
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Computerized Cognitive Assessment Aid For Concussion
Device Class: Class II
Regulation Number: 882.1471
Review Panel: NE
Submission Type

For use as an assessment aid in the management of concussion.