STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE


Device Classification Name

neurological stereotaxic instrument

510(k) Number K030106
Device Name STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE
Original Applicant
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 coal creek circle
louisville, 
CO 
80027

Original Contact victoria g rendon
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 01/13/2003
Decision Date 02/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No