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FDA 510(k)

Deltex醫療 CardioQ-EDM+，Deltex醫療 CardioQ-EDM

K 號：K172457 · 2018-06-28

申請人Deltex Medical Limited
決定日期2018-06-28
產品代碼DPW
諮詢委員會履歷
決定相當於

器材摘要

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is the device name listed in this FDA 510(k) record. The listed applicant is Deltex Medical Limited. It received FDA 510(k) clearance on 2018-06-28 under 510(k) number K172457. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is a medical device that received FDA 510(k) clearance on 2018-06-28. The listed applicant is Deltex Medical Limited. The 510(k) number is K172457.

When did Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM receive FDA 510(k) clearance?

Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM received FDA 510(k) clearance on 2018-06-28, under 510(k) number K172457.

Who is the listed applicant for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

The FDA 510(k) record lists Deltex Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM?

The FDA product code for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM is DPW.

相關臨床試驗

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。

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相關器械（代碼：DPW）

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。

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官方來源

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