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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter Remote Control System
510(k) Number K192775
Device Name Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri
Applicant
Stereotaxis, Inc.
4320 Forest Park Avenue, Suite 100
St. Louis,  MO  63108
Applicant Contact Kenneth H. Lock
Correspondent
Stereotaxis, Inc.
4320 Forest Park Avenue, Suite 100
St. Louis,  MO  63108
Correspondent Contact Kenneth H. Lock
Regulation Number870.5700
Classification Product Code
PJB  
Subsequent Product Code
NDQ  
Date Received09/30/2019
Decision Date 10/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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