FDA 510(k)

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

K-Number: K220935 · 2022-12-29

Decision Date2022-12-29

Product CodeFKX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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Related Devices (Code: FKX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.