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510(k) K202485

ImPACT Version 4 by Impact Applications, Inc. — Product Code POM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 25, 2020
Date Received: August 31, 2020
Clearance Type: Traditional
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.

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