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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 K181223
Device Name ImPACT
Applicant
ImPACT Applications, Inc.
9665 Granite Ridge Drive, Suite 550
San Diego,  CA  92123
Applicant Contact Michael Zagorski
Correspondent
ImPACT Applications, Inc.
9665 Granite Ridge Drive, Suite 550
San Diego,  CA  92123
Correspondent Contact Michael Zagorski
Regulation Number882.1471
Classification Product Code
POM  
Date Received05/08/2018
Decision Date 10/20/2018
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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