FDA 510(k) Application Details - K212788

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K212788
Device Name	Electroencephalograph
Applicant	Seer Medical Pty Ltd Melbourne 3133 AU Other 510(k) Applications for this Company
Contact	David Mitchell Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	GWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2021
Decision Date	06/16/2022
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