FDA 510(k), K220935, Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App

FDA 510(k), K220935, Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App

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510(K) Number: K220935
Device Name: Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
Manufacturer: Hezkiah Tsoory
Device Classification Name: System, Peritoneal, Automatic Delivery
Regulation Number: FKX
Classification Product Code: 03/31/2022
Date Received: 12/29/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology

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