510(k) DEN130033
DEN130033 is an FDA 510(k) premarket notification submitted by Cerebral Assessment Systems, Inc. for the device "COGNIVUE". The FDA issued a decision of De Novo Granted on June 5, 2015. The device falls under product code PKQ (Computerized Cognitive Assessment Aid), a Class II device regulated under 21 CFR 882.1470.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 5, 2015
- Date Received
- June 12, 2013
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computerized Cognitive Assessment Aid
- Device Class
- Class II
- Regulation Number
- 882.1470
- Review Panel
- NE
- Submission Type
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