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FDA 510(k)

CardioDay V2.5

K-Number: K162023 · 2017-03-24

ApplicantGetemed Medizin- Und Informationstechnik AG
Decision Date2017-03-24
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardioDay V2.5 is a medical device manufactured by Getemed Medizin- Und Informationstechnik AG. It received FDA 510(k) clearance on 2017-03-24 under approval number K162023. 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 CardioDay V2.5?

CardioDay V2.5 is a medical device that received FDA 510(k) clearance on 2017-03-24. It is manufactured by Getemed Medizin- Und Informationstechnik AG. The 510(k) number is K162023.

When was CardioDay V2.5 approved by the FDA?

CardioDay V2.5 received FDA 510(k) clearance on 2017-03-24, under approval number K162023.

What company makes CardioDay V2.5?

CardioDay V2.5 is manufactured by Getemed Medizin- Und Informationstechnik AG.

What is the FDA product code for CardioDay V2.5?

The FDA product code for CardioDay V2.5 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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