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FDA 510(k)

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

K-Number: K193670 · 2020-12-23

ApplicantQuanta Dialysis Technologies, Ltd.
Decision Date2020-12-23
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set is a medical device manufactured by Quanta Dialysis Technologies, Ltd.. It received FDA 510(k) clearance on 2020-12-23 under approval number K193670. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set is a medical device that received FDA 510(k) clearance on 2020-12-23. It is manufactured by Quanta Dialysis Technologies, Ltd.. The 510(k) number is K193670.

When was SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set approved by the FDA?

SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set received FDA 510(k) clearance on 2020-12-23, under approval number K193670.

What company makes SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set is manufactured by Quanta Dialysis Technologies, Ltd..

What is the FDA product code for SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

The FDA product code for SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set is KDI.

Related Clinical Trials

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Other Devices by Quanta Dialysis Technologies, Ltd.

K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)

Related Devices (Code: KDI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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