K193147

Substantially Equivalent

Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System

Applicant: Stereotaxis, Inc.
Product code: PJB
Advisory panel: Cardiovascular
Date received: 2019-11-13
Decision date: 2020-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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