NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION— 510(k) K060967

Name: FDA 510(k) clearance K060967
Creator: U.S. Food and Drug Administration
Published: 2006-10-19

Substantially Equivalent

Stereotaxis, Inc.

FDA 510(k) clearance K060967 for NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION, Substantially Equivalent on 2006-10-19. Applicant: Stereotaxis, Inc.. Device class: 2.

Clearance details

Applicant: Stereotaxis, Inc.
Product code: Code NDQ
Device class: Class 2
Regulation: 21 CFR 870.1290
Advisory panel: Cardiovascular
Date received: 2006-04-07
Decision date: 2006-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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