ImPACT Version 4

Computerized Cognitive Assessment Aid For Concussion

ImPACT Applications, Inc.

The following data is part of a premarket notification filed by Impact Applications, Inc. with the FDA for Impact Version 4.

Pre-market Notification Details

Device IDK202485
510k NumberK202485
Device Name:ImPACT Version 4
ClassificationComputerized Cognitive Assessment Aid For Concussion
Applicant ImPACT Applications, Inc. 2140 Norcor Ave., Suite 115 Coralville,  IA  52241
ContactMichael Zagorski
CorrespondentMichael Zagorski
ImPACT Applications, Inc. 2140 Norcor Ave., Suite 115 Coralville,  IA  52241
Product CodePOM  
CFR Regulation Number882.1471 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-31
Decision Date2020-12-25

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