FDA 510(k) Application Details - K202927

Device Classification Name	More FDA Info for this Device
510(K) Number	K202927
Device Name	EYE-SYNC
Applicant	SyncThink, Inc. 2172 Staunton Court Palo Alto, CA 94306 US Other 510(k) Applications for this Company
Contact	Dan Beeler Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2020
Decision Date	10/02/2021
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