FDA 510(k) Application Details - K161701

Device Classification Name	More FDA Info for this Device
510(K) Number	K161701
Device Name	CARTO ENT System
Applicant	BIOSENSE WEBSTER 3333 DIAMOND CANYON ROAD DIAMOND BAR, CA 91765 US Other 510(k) Applications for this Company
Contact	MELISSA C. SCHULTZ Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2016
Decision Date	10/24/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review