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FDA 510(k)

CARDIODAY, VERSION 2.0

K-Number: K070280 · 2007-02-23

ApplicantGetemed Medizin- Und Informationstechnik AG
Decision Date2007-02-23
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIODAY, VERSION 2.0 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 2007-02-23 under 510(k) number K070280. 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, VERSION 2.0?

CARDIODAY, VERSION 2.0 is a medical device that received FDA 510(k) clearance on 2007-02-23. The listed applicant is Getemed Medizin- Und Informationstechnik AG. The 510(k) number is K070280.

When did CARDIODAY, VERSION 2.0 receive FDA 510(k) clearance?

CARDIODAY, VERSION 2.0 received FDA 510(k) clearance on 2007-02-23, under 510(k) number K070280.

Who is the listed applicant for CARDIODAY, VERSION 2.0?

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, VERSION 2.0?

The FDA product code for CARDIODAY, VERSION 2.0 is DQK.

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Other records listing Getemed Medizin- Und Informationstechnik AG as applicant

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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.

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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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