佳明心電圖應用程式
K 號：K221774 · 2023-01-12
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器材摘要
Garmin ECG App is the device name listed in this FDA 510(k) record. The listed applicant is Garmin International, Inc.. It received FDA 510(k) clearance on 2023-01-12 under 510(k) number K221774. The device is classified under product code QDA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Garmin ECG App?
Garmin ECG App is a medical device that received FDA 510(k) clearance on 2023-01-12. The listed applicant is Garmin International, Inc.. The 510(k) number is K221774.
When did Garmin ECG App receive FDA 510(k) clearance?
Garmin ECG App received FDA 510(k) clearance on 2023-01-12, under 510(k) number K221774.
Who is the listed applicant for Garmin ECG App?
The FDA 510(k) record lists Garmin International, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Garmin ECG App?
The FDA product code for Garmin ECG App is QDA.
相關臨床試驗
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相關器械（代碼：QDA）
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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