STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM


Device Classification Name

system, catheter control, steerable

510(k) Number K021555
Device Name STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
Original Applicant
STEREOTAXIS, INC.
4041 forest park ave.
st. louis, 
MO 
63108

Original Contact peter a takes
Regulation Number 870.1290
Classification Product Code
DXX  
Date Received 05/13/2002
Decision Date 01/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No