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FDA 510(k)

CardioDay V2.5

K 號:K162023 · 2017-03-24

決定日期2017-03-24
產品代碼DQK
諮詢委員會履歷
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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相關器械(代碼:DQK)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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