Vdrive system, Vdrive Duo, Vdrive with V-Sono— 510(k) K150312

Substantially Equivalent

Stereotaxis, Inc.

FDA 510(k) clearance K150312 for Vdrive system, Vdrive Duo, Vdrive with V-Sono, Substantially Equivalent on 2015-06-17. Applicant: Stereotaxis, Inc..

Clearance details

Applicant: Stereotaxis, Inc.
Product code: Code DXX
Advisory panel: Cardiovascular
Date received: 2015-02-09
Decision date: 2015-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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