Medical Device Manufacturer · US , Pittsburgh , PA

Impact Applications, Inc. - FDA 510(k) Cleared Devices

6 submissions · 5 cleared · Since 2016

Recent clearances: ImPACT Version 4, ImPACT Version 4, ImPACT

6

Total

5

Cleared

1

Denied

FDA 510(k) Regulatory Record - Impact Applications, Inc. Neurology ✕

6 devices

1-6 of 6

Cleared Sep 16, 2023

ImPACT Version 4

Neurology · 99d

Cleared Dec 25, 2020

ImPACT Version 4

Neurology · 116d

Cleared Oct 20, 2018

Neurology · 165d

Cleared Jun 21, 2017

ImPACT Quick Test

Neurology · 117d

Cleared Feb 23, 2017

Neurology · 30d

Not Cleared Aug 22, 2016

ImPACT Computerized Neurocognitive Concussion Management Aid

DEN150037 · POM

Neurology · 377d