510(k) K161328
K161328 is an FDA 510(k) premarket notification submitted by Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd. for the device "Cantab Mobile". The FDA issued a decision of Substantially Equivalent on January 13, 2017. The device falls under product code PKQ (Computerized Cognitive Assessment Aid), a Class II device regulated under 21 CFR 882.1470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2017
- Date Received
- May 12, 2016
- Clearance Type
- Traditional
- 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