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FDA 510(k) Applications for Medical Device Product Code "POM"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K170209
IMPACT APPLICATIONS, INC
ImPACT
02/23/2017
K181223
ImPACT Applications, Inc.
ImPACT
10/20/2018
DEN150037
IMPACT APPLICATIONS, INC.
ImPACT Computerized Neurocognitive Concussion Management Aid
08/22/2016
K170551
ImPACT Applications, Inc.
ImPACT Quick Test
06/21/2017
K202485
ImPACT Applications, Inc.
ImPACT Version 4
12/25/2020
K231688
ImPACT Applications, Inc.
ImPACT Version 4
09/16/2023
K201376
Vista LifeSciences, Inc.
ANAM Test System
03/25/2021
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