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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 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.

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. 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.

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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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