FDA 510(k) Application Details - DEN200069

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200069
Device Name	Cognoa ASD Diagnosis Aid
Applicant	Cognoa, Inc. 2185 Park Blvd. Palo Alto, CA 94306 US Other 510(k) Applications for this Company
Contact	Sophie Dessalle 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	11/03/2020
Decision Date	06/02/2021
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review