FDA 510(k) Application Details - K230814

Device Classification Name	More FDA Info for this Device
510(K) Number	K230814
Device Name	VRNT
Applicant	CognifiSense, Inc. 1271 Lakeside Drive, Suite 3121 Sunnyvale, CA 94085 US Other 510(k) Applications for this Company
Contact	Tassilo Baeuerle Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2023
Decision Date	10/31/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review