FDA 510(k) Application Details - K192775

Device Classification Name	More FDA Info for this Device
510(K) Number	K192775
Device Name	Niobe« Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
Applicant	Stereotaxis, Inc. 4320 Forest Park Avenue, Suite 100 St. Louis, MO 63108 US Other 510(k) Applications for this Company
Contact	Kenneth H. Lock Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2019
Decision Date	10/30/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review