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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 Control, Steerable
510(k) Number K032937
Device Name NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500
Applicant
Stereotaxis, Inc.
4041 Forest Park Ave.
Saint Louis,  MO  63108
Applicant Contact PETER A TAKES
Correspondent
Stereotaxis, Inc.
4041 Forest Park Ave.
Saint Louis,  MO  63108
Correspondent Contact PETER A TAKES
Regulation Number870.1290
Classification Product Code
DXX  
Date Received09/22/2003
Decision Date 07/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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