FDA 510(k)

CardioDay V2.5

Numéro K : K162023 · 2017-03-24

DemandeurGetemed Medizin- Und Informationstechnik AG

Date de décision2017-03-24

Code produitDQK

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

CardioDay V2.5 is the device name listed in this FDA 510(k) record. The listed applicant is Getemed Medizin- Und Informationstechnik AG. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162023. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CardioDay V2.5?

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

When did CardioDay V2.5 receive FDA 510(k) clearance?

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

Who is the listed applicant for CardioDay V2.5?

The FDA 510(k) record lists Getemed Medizin- Und Informationstechnik AG as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for CardioDay V2.5 is DQK.

Essais cliniques associés

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Source officielle

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