510(k) DEN150037
- Device
- ImPACT Computerized Neurocognitive Concussion Management Aid
- Applicant
- Impact Applications, Inc.
- 510(k) number
- DEN150037
- Product code
- POM
- Decision
- Unknown (DENG)
- Decision date
- 2016-08-22
- Date received
- 2015-08-11
- Regulation
- 882.1471
- Classification name
- Computerized Cognitive Assessment Aid For Concussion
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- MICHAEL ZAGORSKI
- Address
- 2000 Technology Dr., Suite 150 Pittsburgh PA US 15219 15219
FDA Registration Numbers#
- 3012102743
- 3010325634
- 3011279934
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code POM#
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|---|---|---|---|
| K241737 | Sway System Sports Plus | Sway Medical, Inc. | 2025-02-15 |
| K231688 | ImPACT Version 4 | Impact Applications, Inc. | 2023-09-16 |
| K201376 | ANAM Test System | Vista Lifesciences, Inc. | 2021-03-25 |
| K202485 | ImPACT Version 4 | Impact Applications, Inc. | 2020-12-25 |
| K181223 | ImPACT | Impact Applications, Inc. | 2018-10-20 |
| K170551 | ImPACT Quick Test | Impact Applications, Inc. | 2017-06-21 |
| K170209 | ImPACT | Impact Applications, Inc. | 2017-02-23 |