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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Catheter Or Guidewire, Steerable (Magnetic)
510(k) Number K060967
Device Name NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
Applicant
Stereotaxis, Inc.
4320 Forest Park Ave., Suite 100
St. Louis,  MO  63108
Applicant Contact DENNIS POZZO
Correspondent
Stereotaxis, Inc.
4320 Forest Park Ave., Suite 100
St. Louis,  MO  63108
Correspondent Contact DENNIS POZZO
Regulation Number870.1290
Classification Product Code
NDQ  
Date Received04/07/2006
Decision Date 10/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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