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
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
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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