Cognoa, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Cognoa, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Canvas Dx
2
Total
1
Cleared
1
Denied
Cognoa, Inc. has 1 FDA 510(k) cleared medical devices. Based in Palo Alto, US.
Latest FDA clearance: Apr 2025. Active since 2021. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Cognoa, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by RQM+ as regulatory consultant. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Cognoa, Inc.
2 devices