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FDA 510(k)

VDRIVE W/V-SONO

K-Number: K122659 · 2013-07-26

ApplicantStereotaxis, Inc.
Decision Date2013-07-26
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VDRIVE W/V-SONO is the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2013-07-26 under 510(k) number K122659. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VDRIVE W/V-SONO?

VDRIVE W/V-SONO is a medical device that received FDA 510(k) clearance on 2013-07-26. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K122659.

When did VDRIVE W/V-SONO receive FDA 510(k) clearance?

VDRIVE W/V-SONO received FDA 510(k) clearance on 2013-07-26, under 510(k) number K122659.

Who is the listed applicant for VDRIVE W/V-SONO?

The FDA 510(k) record lists Stereotaxis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VDRIVE W/V-SONO?

The FDA product code for VDRIVE W/V-SONO is DQX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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