FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ImPACT
K Number: K181223
·
Decision Oct 20, 2018
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
7
Applicant Total
6
Review Days
165
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Basic Information
- Device Name
- ImPACT
- K Number
- K181223
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1471
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Impact Applications, Inc.
- Date Received
- May 8, 2018
- Decision Date
- October 20, 2018
- 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 |
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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 |
| K170551 | ImPACT Quick Test | Jun 21, 2017 | Substantially Equivalent |
| K170209 | ImPACT | Feb 23, 2017 | Substantially Equivalent |
| DEN150037 | ImPACT Computerized Neurocognitive Concussion Management Aid | Aug 22, 2016 | Unknown |