啟示心臟服務器移動版
K 號：K181720 · 2018-07-30
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器材摘要
Epiphany Cardio Server Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Epiphany Healthcare, LLC. It received FDA 510(k) clearance on 2018-07-30 under 510(k) number K181720. 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 Epiphany Cardio Server Mobile?
Epiphany Cardio Server Mobile is a medical device that received FDA 510(k) clearance on 2018-07-30. The listed applicant is Epiphany Healthcare, LLC. The 510(k) number is K181720.
When did Epiphany Cardio Server Mobile receive FDA 510(k) clearance?
Epiphany Cardio Server Mobile received FDA 510(k) clearance on 2018-07-30, under 510(k) number K181720.
Who is the listed applicant for Epiphany Cardio Server Mobile?
The FDA 510(k) record lists Epiphany Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Epiphany Cardio Server Mobile?
The FDA product code for Epiphany Cardio Server Mobile is DQK.
相關臨床試驗
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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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