FDA 510(k) Application Details - K133419

Device Classification Name	Magnetoencephalograph   More FDA Info for this Device
510(K) Number	K133419
Device Name	Magnetoencephalograph
Applicant	TRISTAN TECHNOLOGIES INC 3365 CALLE MARGARITA ENCINITAS, CA 92024 US Other 510(k) Applications for this Company
Contact	EUGENE HIRSCHKOFF 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	11/07/2013
Decision Date	07/21/2014
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