The following data is part of a premarket notification filed by Impact Applications, Inc. with the FDA for Impact Version 4.
Device ID | K202485 |
510k Number | K202485 |
Device Name: | ImPACT Version 4 |
Classification | Computerized Cognitive Assessment Aid For Concussion |
Applicant | ImPACT Applications, Inc. 2140 Norcor Ave., Suite 115 Coralville, IA 52241 |
Contact | Michael Zagorski |
Correspondent | Michael Zagorski ImPACT Applications, Inc. 2140 Norcor Ave., Suite 115 Coralville, IA 52241 |
Product Code | POM |
CFR Regulation Number | 882.1471 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-08-31 |
Decision Date | 2020-12-25 |