SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Quanta Dialysis Technologies Ltd.

The following data is part of a premarket notification filed by Quanta Dialysis Technologies Ltd. with the FDA for Sc+ Haemodialysis Machine, Sc+ Dialysate Cartridge, Sc+ Blood Tube Set.

Pre-market Notification Details

Device IDK193670
510k NumberK193670
Device Name:SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant Quanta Dialysis Technologies Ltd. Tything Road Alcester,  GB B49 6eu
ContactChris Rule
CorrespondentChris Rule
Quanta Dialysis Technologies Ltd. Tything Road Alcester,  GB B49 6eu
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-31
Decision Date2020-12-23

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