Stereotaxis Genesis RMN With Navigant Workstation (NWS) And Cardiodrive System

Catheter Remote Control System

Stereotaxis, Inc.

The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Stereotaxis Genesis Rmn With Navigant Workstation (nws) And Cardiodrive System.

Pre-market Notification Details

Device IDK193147
510k NumberK193147
Device Name:Stereotaxis Genesis RMN With Navigant Workstation (NWS) And Cardiodrive System
ClassificationCatheter Remote Control System
Applicant Stereotaxis, Inc. 4320 Forest Park Avenue, Suite 100 St. Louis,  MO  63108
ContactKenneth H. Lock
CorrespondentKenneth H. Lock
Stereotaxis, Inc. 4320 Forest Park Avenue, Suite 100 St. Louis,  MO  63108
Product CodePJB  
CFR Regulation Number870.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-13
Decision Date2020-03-05

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