FDA 510(k), K193670, SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

510(K) Number: K193670
Device Name: SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
Manufacturer: Quanta Dialysis Technologies Ltd.
Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation Number: 876.5860
Classification Product Code: KDI
Date Received: 12/31/2019
Decision Date: 12/23/2020
Regulation Medical Specialty: Gastroenterology/Urology

515 pages (1,391 of 1,906 original pages are fully redacted)