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FDA 510(k)

Cordiana Dx16

K-Number: K201060 · 2020-11-16

ApplicantCordiana Medical Informatics AG
Decision Date2020-11-16
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cordiana Dx16 is a medical device manufactured by Cordiana Medical Informatics AG. It received FDA 510(k) clearance on 2020-11-16 under approval number K201060. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cordiana Dx16?

Cordiana Dx16 is a medical device that received FDA 510(k) clearance on 2020-11-16. It is manufactured by Cordiana Medical Informatics AG. The 510(k) number is K201060.

When was Cordiana Dx16 approved by the FDA?

Cordiana Dx16 received FDA 510(k) clearance on 2020-11-16, under approval number K201060.

What company makes Cordiana Dx16?

Cordiana Dx16 is manufactured by Cordiana Medical Informatics AG.

What is the FDA product code for Cordiana Dx16?

The FDA product code for Cordiana Dx16 is DQK.

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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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