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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 K193147
Device Name Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
Applicant
Stereotaxis, Inc.
4320 Forest Park Ave., Suite 100
St. Louis,  MO  63108
Applicant Contact Kenneth H. Lock
Correspondent
Stereotaxis, Inc.
4320 Forest Park Ave., Suite 100
St. Louis,  MO  63108
Correspondent Contact Kenneth H. Lock
Regulation Number870.5700
Classification Product Code
PJB  
Subsequent Product Code
NDQ  
Date Received11/13/2019
Decision Date 03/05/2020
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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