CardioFlux 配合法拉第分析雲
K 號：K182571 · 2019-03-15
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器材摘要
CardioFlux with Faraday Analytical Cloud is the device name listed in this FDA 510(k) record. The listed applicant is Genetesis, Inc.. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K182571. 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 CardioFlux with Faraday Analytical Cloud?
CardioFlux with Faraday Analytical Cloud is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Genetesis, Inc.. The 510(k) number is K182571.
When did CardioFlux with Faraday Analytical Cloud receive FDA 510(k) clearance?
CardioFlux with Faraday Analytical Cloud received FDA 510(k) clearance on 2019-03-15, under 510(k) number K182571.
Who is the listed applicant for CardioFlux with Faraday Analytical Cloud?
The FDA 510(k) record lists Genetesis, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CardioFlux with Faraday Analytical Cloud?
The FDA product code for CardioFlux with Faraday Analytical Cloud 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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