節律分析器
K 號：K182344 · 2019-03-07
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器材摘要
RhythmAnalytics is the device name listed in this FDA 510(k) record. The listed applicant is Biofourmis Singapore Pte., Ltd.. It received FDA 510(k) clearance on 2019-03-07 under 510(k) number K182344. 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 RhythmAnalytics?
RhythmAnalytics is a medical device that received FDA 510(k) clearance on 2019-03-07. The listed applicant is Biofourmis Singapore Pte., Ltd.. The 510(k) number is K182344.
When did RhythmAnalytics receive FDA 510(k) clearance?
RhythmAnalytics received FDA 510(k) clearance on 2019-03-07, under 510(k) number K182344.
Who is the listed applicant for RhythmAnalytics?
The FDA 510(k) record lists Biofourmis Singapore Pte., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RhythmAnalytics?
The FDA product code for RhythmAnalytics is DQK.
相關臨床試驗
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其他以 Biofourmis Singapore Pte., Ltd. 為申請人之記錄
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。
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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