CardiMax 電子心電圖機
K 號：K173226 · 2018-04-16
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器材摘要
CardiMax Electrocardiograph is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 2018-04-16 under 510(k) number K173226. 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 CardiMax Electrocardiograph?
CardiMax Electrocardiograph is a medical device that received FDA 510(k) clearance on 2018-04-16. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K173226.
When did CardiMax Electrocardiograph receive FDA 510(k) clearance?
CardiMax Electrocardiograph received FDA 510(k) clearance on 2018-04-16, under 510(k) number K173226.
Who is the listed applicant for CardiMax Electrocardiograph?
The FDA 510(k) record lists Fukuda Denshi USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CardiMax Electrocardiograph?
The FDA product code for CardiMax Electrocardiograph is DPS.
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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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