AI-ECG 追踪器
K 號：K200036 · 2020-03-20
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器材摘要
AI-ECG Tracker is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Carewell Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K200036. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AI-ECG Tracker?
AI-ECG Tracker is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Shenzhen Carewell Electronics Co., Ltd.. The 510(k) number is K200036.
When did AI-ECG Tracker receive FDA 510(k) clearance?
AI-ECG Tracker received FDA 510(k) clearance on 2020-03-20, under 510(k) number K200036.
Who is the listed applicant for AI-ECG Tracker?
The FDA 510(k) record lists Shenzhen Carewell Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AI-ECG Tracker?
The FDA product code for AI-ECG Tracker is DPS.
相關臨床試驗
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相關器械（代碼：DPS）
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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