FDA 510(k) Application Details - K191785

Device Classification Name	Magnetoencephalograph   More FDA Info for this Device
510(K) Number	K191785
Device Name	Magnetoencephalograph
Applicant	Compumedics Limited 30-40 Flockhart Street Abbotsford 3067 AU Other 510(k) Applications for this Company
Contact	William Alam Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2019
Decision Date	02/14/2020
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	N
Expedited Review