Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri— 510(k) K192775

Substantially Equivalent

Stereotaxis, Inc.

FDA 510(k) clearance K192775 for Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri, Substantially Equivalent on 2019-10-30. Applicant: Stereotaxis, Inc..

Clearance details

Applicant: Stereotaxis, Inc.
Product code: Code PJB
Advisory panel: Cardiovascular
Date received: 2019-09-30
Decision date: 2019-10-30
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Louis, MO, US

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