SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset

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+ Hemodialysis Machine, Sc+ Dialysate Cartridge, Sc+ Blood Tubeset.

Pre-market Notification Details

Device IDK210661
510k NumberK210661
Device Name:SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant Quanta Dialysis Technologies Ltd Tything Road Alcester,  GB B49 6eu
ContactSam Drew
CorrespondentSam Drew
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 Received2021-03-04
Decision Date2021-08-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.