FDA 510(k) Application Details - K060967

Device Classification Name	System, Catheter Or Guidewire, Steerable (Magnetic)   More FDA Info for this Device
510(K) Number	K060967
Device Name	System, Catheter Or Guidewire, Steerable (Magnetic)
Applicant	STEREOTAXIS, INC. 4320 FOREST PARK AVENUE SUITE 100 ST. LOUIS, MO 63108 US Other 510(k) Applications for this Company
Contact	DENNIS POZZO Other 510(k) Applications for this Contact
Regulation Number	870.1290   More FDA Info for this Regulation Number
Classification Product Code	NDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2006
Decision Date	10/19/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review