FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ImPACT Computerized Neurocognitive Concussion Management Aid
K Number: DEN150037
·
Decision Aug 22, 2016
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
7
Applicant Total
6
Review Days
377
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ImPACT Computerized Neurocognitive Concussion Management Aid
- K Number
- DEN150037
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.1471
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Impact Applications, Inc.
- Date Received
- August 11, 2015
- Decision Date
- August 22, 2016
- Product Code
- POM
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| POM | Computerized Cognitive Assessment Aid For Concussion | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (POM), ordered by most recent decision date.
Sway System Sports Plus
FDA 510(k)
FDA Class 2
·Neurology
ImPACT Version 4
FDA 510(k)
FDA Class 2
·Neurology
ANAM Test System
FDA 510(k)
FDA Class 2
·Neurology
ImPACT Version 4
FDA 510(k)
FDA Class 2
·Neurology
ImPACT
FDA 510(k)
FDA Class 2
·Neurology
ImPACT Quick Test
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Impact Applications, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231688 | ImPACT Version 4 | Sep 16, 2023 | Substantially Equivalent |
| K202485 | ImPACT Version 4 | Dec 25, 2020 | Substantially Equivalent |
| K181223 | ImPACT | Oct 20, 2018 | Substantially Equivalent |
| K170551 | ImPACT Quick Test | Jun 21, 2017 | Substantially Equivalent |
| K170209 | ImPACT | Feb 23, 2017 | Substantially Equivalent |