FDA 510(k) Application Details - K243558

Device Classification Name	More FDA Info for this Device
510(K) Number	K243558
Device Name	Canvas Dx
Applicant	Cognoa, Inc. 2185 Park Blvd. Palo Alto, CA 94306 US Other 510(k) Applications for this Company
Contact	Sharief Taraman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2024
Decision Date	04/11/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review