DeviceClearance

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

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..

Clearance details

Applicant
Stereotaxis, Inc.
Product code
Code PJB
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Louis, MO, US
Download summary PDFView on FDA.gov ↗

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