Device |
computerized cognitive assessment aid |
Regulation Description |
Computerized cognitive assessment aid. |
Definition |
The computerized cognitive assessment aid provides clinicians in a healthcare setting with objective measurements of cognitive function as a screening aid in the assessment of adults 55 years of age and older. This is done for the purpose of identifying a potential decline in cognitive function relative to baseline test performance of other age-normal adults, referring those adults for further testing where warranted, and monitoring changes in cognitive function over time |
Physical State |
Computer-administered battery of cognitive tests, computer keyboard, computer screen. |
Technical Method |
Uses a battery of objective cognitive tests delivered by computer software to determine an individual's current level of cognitive functioning. |
Target Area |
Brain |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | PKQ |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
Submission Type |
510(k)
|
Regulation Number |
882.1470
|
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 |