FDA 510(k) Application Details - K192397

Device Classification Name	More FDA Info for this Device
510(K) Number	K192397
Device Name	TruDi Navigation System
Applicant	Biosense Webster 33 Technology Drive Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	David Locke 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	09/03/2019
Decision Date	01/30/2020
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