510(k) K220935
Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App by
Iren-Medical, Ltd.
— Product Code FKX
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 2022
- Date Received
- March 31, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Peritoneal, Automatic Delivery
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type