心輝艾米高™系統
K 號：K231424 · 2024-12-13
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器材摘要
HeartBeam AIMIGo(TM) System is the device name listed in this FDA 510(k) record. The listed applicant is Heartbeam, Inc.. It received FDA 510(k) clearance on 2024-12-13 under 510(k) number K231424. 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 HeartBeam AIMIGo(TM) System?
HeartBeam AIMIGo(TM) System is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is Heartbeam, Inc.. The 510(k) number is K231424.
When did HeartBeam AIMIGo(TM) System receive FDA 510(k) clearance?
HeartBeam AIMIGo(TM) System received FDA 510(k) clearance on 2024-12-13, under 510(k) number K231424.
Who is the listed applicant for HeartBeam AIMIGo(TM) System?
The FDA 510(k) record lists Heartbeam, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HeartBeam AIMIGo(TM) System?
The FDA product code for HeartBeam AIMIGo(TM) System is MWJ.
相關臨床試驗
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其他以 Heartbeam, Inc. 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：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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