COGNIVUE

Computerized Cognitive Assessment Aid

CEREBRAL ASSESSMENT SYSTEMS, INC

The following data is part of a De Novo classification by Cerebral Assessment Systems, Inc with the FDA for Cognivue.

Pre-market Notification Details

• DeNovo ID: DEN130033
• Device Name: COGNIVUE
• Classification: Computerized Cognitive Assessment Aid
• Applicant: CEREBRAL ASSESSMENT SYSTEMS, INC 10 Pond View Drive Pittsford, NY 14534
• Contact: Charles J Duffy
• Product Code: PKQ
• CFR Regulation Number: 882.1470 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
• Review Advisory Board: Neurology
• Classification Advisory: Neurology
• Type: Direct
• Date Received: 2013-06-12
• Decision Date: 2015-06-05
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860000564014	DEN130033	000
00860000564007	DEN130033	000