FDA 510(k) Application Details - K051373

Device Classification Name	System, Catheter Or Guidewire, Steerable (Magnetic)   More FDA Info for this Device
510(K) Number	K051373
Device Name	System, Catheter Or Guidewire, Steerable (Magnetic)
Applicant	STEREOTAXIS, INC. 4041 FOREST PARK AVE. ST. LOUIS, MO 63108 US Other 510(k) Applications for this Company
Contact	KELLY ROWLAND 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	05/26/2005
Decision Date	12/09/2005
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