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FDA 510(k)

MEDVOXEL HEARTPRO SOFTWARE APPLICATION

K-Number: K103565 · 2011-04-12

ApplicantMedvoxel Systems, Inc.
Decision Date2011-04-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDVOXEL HEARTPRO SOFTWARE APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Medvoxel Systems, Inc.. It received FDA 510(k) clearance on 2011-04-12 under 510(k) number K103565. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDVOXEL HEARTPRO SOFTWARE APPLICATION?

MEDVOXEL HEARTPRO SOFTWARE APPLICATION is a medical device that received FDA 510(k) clearance on 2011-04-12. The listed applicant is Medvoxel Systems, Inc.. The 510(k) number is K103565.

When did MEDVOXEL HEARTPRO SOFTWARE APPLICATION receive FDA 510(k) clearance?

MEDVOXEL HEARTPRO SOFTWARE APPLICATION received FDA 510(k) clearance on 2011-04-12, under 510(k) number K103565.

Who is the listed applicant for MEDVOXEL HEARTPRO SOFTWARE APPLICATION?

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

What is the FDA product code for MEDVOXEL HEARTPRO SOFTWARE APPLICATION?

The FDA product code for MEDVOXEL HEARTPRO SOFTWARE APPLICATION is LLZ.

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Official Source

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

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