FDA 510(k)

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

Номер K: K220935 · 2022-12-29

Дата решения2022-12-29

Код продуктаFKX

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: FKX)

K250523Archimedes Pro Автоматический Цикл Перитонеального Диализа (3014-00000-1); Archimedes Standard Автоматический Цикл Перитонеального Диализа (3014-00000-3); Archimedes Pro Одноразовый Набор Трубок (3014-50000-1); Archimedes Standard Одноразовый Набор Трубок (3014-50000-3); Archimedes Pro Plus Одноразовый Набор Трубок (3014-50000-5)Simergent, LLC K243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd.K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC K212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLC K212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcath K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemBaxter Healthcare Corporation

Официальный источник

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