HeartKey® 节律
K 號：K233755 · 2024-08-16
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器材摘要
HeartKey® Rhythm is the device name listed in this FDA 510(k) record. The listed applicant is B-Secur Limited. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K233755. 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 HeartKey® Rhythm?
HeartKey® Rhythm is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is B-Secur Limited. The 510(k) number is K233755.
When did HeartKey® Rhythm receive FDA 510(k) clearance?
HeartKey® Rhythm received FDA 510(k) clearance on 2024-08-16, under 510(k) number K233755.
Who is the listed applicant for HeartKey® Rhythm?
The FDA 510(k) record lists B-Secur Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HeartKey® Rhythm?
The FDA product code for HeartKey® Rhythm 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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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