STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE


Device Classification Name

neurological stereotaxic instrument

510(k) Number K022414
Device Name STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE
Original Applicant
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
826 coal creek cir.
louisville, 
CO 
80027

Original Contact victoria g rendon
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 07/24/2002
Decision Date 08/14/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No