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FDA 510(k)

CardioFlux with Faraday Analytical Cloud

K-Number: K182571 · 2019-03-15

ApplicantGenetesis, Inc.
Decision Date2019-03-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardioFlux with Faraday Analytical Cloud is a medical device manufactured by Genetesis, Inc.. It received FDA 510(k) clearance on 2019-03-15 under approval number K182571. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CardioFlux with Faraday Analytical Cloud?

CardioFlux with Faraday Analytical Cloud is a medical device that received FDA 510(k) clearance on 2019-03-15. It is manufactured by Genetesis, Inc.. The 510(k) number is K182571.

When was CardioFlux with Faraday Analytical Cloud approved by the FDA?

CardioFlux with Faraday Analytical Cloud received FDA 510(k) clearance on 2019-03-15, under approval number K182571.

What company makes CardioFlux with Faraday Analytical Cloud?

CardioFlux with Faraday Analytical Cloud is manufactured by Genetesis, Inc..

What is the FDA product code for CardioFlux with Faraday Analytical Cloud?

The FDA product code for CardioFlux with Faraday Analytical Cloud is DPS.

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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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