FDA 510(k) Application Details - K150312

Device Classification Name	System, Catheter Control, Steerable   More FDA Info for this Device
510(K) Number	K150312
Device Name	System, Catheter Control, Steerable
Applicant	STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 ST. LOUIS, MO 63108 US Other 510(k) Applications for this Company
Contact	JOHN NADELIN Other 510(k) Applications for this Contact
Regulation Number	870.1290   More FDA Info for this Regulation Number
Classification Product Code	DXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/09/2015
Decision Date	06/17/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review