Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System— 510(k) K193147

Name: FDA 510(k) clearance K193147
Creator: U.S. Food and Drug Administration
Published: 2020-03-05

Substantially Equivalent

Stereotaxis, Inc.

FDA 510(k) clearance K193147 for Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System, Substantially Equivalent on 2020-03-05. Applicant: Stereotaxis, Inc.. Device class: 2.

Clearance details

Applicant: Stereotaxis, Inc.
Product code: Code PJB
Device class: Class 2
Regulation: 21 CFR 870.5700
Advisory panel: Cardiovascular
Date received: 2019-11-13
Decision date: 2020-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.