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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computerized cognitive assessment aid for concussion
510(k) Number K202485
Device Name ImPACT Version 4
Applicant
ImPACT Applications, Inc.
2140 Norcor Ave., Suite 115
Coralville,  IA  52241
Applicant Contact Michael Zagorski
Correspondent
ImPACT Applications, Inc.
2140 Norcor Ave., Suite 115
Coralville,  IA  52241
Correspondent Contact Michael Zagorski
Regulation Number882.1471
Classification Product Code
POM  
Date Received08/31/2020
Decision Date 12/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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