Device |
computerized cognitive assessment aid for concussion |
Regulation Description |
Computerized cognitive assessment aid for concussion. |
Definition |
For use as an assessment aid in the management of concussion. |
Physical State |
The device consists of a software program that administers a neurocognitive test battery to a subject in order to assess their cognitive status. The device may use off-the-shelf computers or a novel device. |
Technical Method |
Uses a software-based cognitive test battery as an assessment aid in the management of concussion. |
Target Area |
Brain |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | POM |
Premarket Review |
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
Submission Type |
510(k)
|
Regulation Number |
882.1471
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |