FDA 510(k) Application Details - K200705

Device Classification Name	Stimulator, Photic, Evoked Response   More FDA Info for this Device
510(K) Number	K200705
Device Name	Stimulator, Photic, Evoked Response
Applicant	Cryptych Pty Ltd Level 15, Suite 1502, 275 Alfred Street North Sydney 2060 AU Other 510(k) Applications for this Company
Contact	Angela Roche Other 510(k) Applications for this Contact
Regulation Number	882.1890   More FDA Info for this Regulation Number
Classification Product Code	GWE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2020
Decision Date	04/23/2020
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	Y
Expedited Review