Niobe® Magnetic Navigation System (MNS) With Navigant Workstation (NWS) And Cardiodri

Catheter Remote Control System

Stereotaxis, Inc.

The following data is part of a premarket notification filed by Stereotaxis, Inc. with the FDA for Niobe® Magnetic Navigation System (mns) With Navigant Workstation (nws) And Cardiodri.

Pre-market Notification Details

Device IDK192775
510k NumberK192775
Device Name:Niobe® Magnetic Navigation System (MNS) With Navigant Workstation (NWS) And Cardiodri
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2019-10-30
Summary:summary

Trademark Results [Niobe]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NIOBE
NIOBE
88293364 not registered Live/Pending
Jones, Sebastian A.
2019-02-07
NIOBE
NIOBE
75816410 2779812 Live/Registered
Stereotaxis, Inc.
1999-10-05
NIOBE
NIOBE
74504133 not registered Dead/Abandoned
Adaptec, Inc.
1994-03-22

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