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FDA 510(k)

數位透析診所 - 智能透析輔助器(IDA)搭配醫療監督入口及IDA行動智慧應用程式

K 號:K220935 · 2022-12-29

決定日期2022-12-29
產品代碼FKX
諮詢委員會GU
決定相當於

器材摘要

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App is the device name listed in this FDA 510(k) record. The listed applicant is Iren-Medical, Ltd.. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K220935. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App?

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Iren-Medical, Ltd.. The 510(k) number is K220935.

When did Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App receive FDA 510(k) clearance?

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App received FDA 510(k) clearance on 2022-12-29, under 510(k) number K220935.

Who is the listed applicant for Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App?

The FDA 510(k) record lists Iren-Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App?

The FDA product code for Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App is FKX.

相關臨床試驗

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:FKX)

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

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