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FDA 510(k)

ProFuse CAD

K-Number: K173744 · 2018-11-21

ApplicantEigen
Decision Date2018-11-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ProFuse CAD is a medical device manufactured by Eigen. It received FDA 510(k) clearance on 2018-11-21 under approval number K173744. 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 ProFuse CAD?

ProFuse CAD is a medical device that received FDA 510(k) clearance on 2018-11-21. It is manufactured by Eigen. The 510(k) number is K173744.

When was ProFuse CAD approved by the FDA?

ProFuse CAD received FDA 510(k) clearance on 2018-11-21, under approval number K173744.

What company makes ProFuse CAD?

ProFuse CAD is manufactured by Eigen.

What is the FDA product code for ProFuse CAD?

The FDA product code for ProFuse CAD is LLZ.

Other Devices by Eigen

K162474Artemis K222222Artemis, Artemis TPO, Artemis MX

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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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