ASSURE 可穿戴心電圖
K 號：K233864 · 2024-05-07
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器材摘要
ASSURE Wearable ECG is the device name listed in this FDA 510(k) record. The listed applicant is Kestra Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-05-07 under 510(k) number K233864. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ASSURE Wearable ECG?
ASSURE Wearable ECG is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Kestra Medical Technologies, Inc.. The 510(k) number is K233864.
When did ASSURE Wearable ECG receive FDA 510(k) clearance?
ASSURE Wearable ECG received FDA 510(k) clearance on 2024-05-07, under 510(k) number K233864.
Who is the listed applicant for ASSURE Wearable ECG?
The FDA 510(k) record lists Kestra Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ASSURE Wearable ECG?
The FDA product code for ASSURE Wearable ECG is MWJ.
相關臨床試驗
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相關器械（代碼：MWJ）
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
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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