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 Number | 882.1471
|
Classification Product Code |
|
Date Received | 08/31/2020 |
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
|
|
|