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FDA 510(k)

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

K-Number: K210661 · 2021-08-12

ApplicantQuanta Dialysis Technologies, Ltd.
Decision Date2021-08-12
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset is a medical device manufactured by Quanta Dialysis Technologies, Ltd.. It received FDA 510(k) clearance on 2021-08-12 under approval number K210661. 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+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset?

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset is a medical device that received FDA 510(k) clearance on 2021-08-12. It is manufactured by Quanta Dialysis Technologies, Ltd.. The 510(k) number is K210661.

When was SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset approved by the FDA?

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset received FDA 510(k) clearance on 2021-08-12, under approval number K210661.

What company makes SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset?

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset is manufactured by Quanta Dialysis Technologies, Ltd..

What is the FDA product code for SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset?

The FDA product code for SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset is KDI.

Related Clinical Trials

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Other Devices by Quanta Dialysis Technologies, Ltd.

K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set 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)

K160558RAPIDO HOLLOW-FIBRE DIALYZERSBellco Srl K160881Tablo ConsoleOutset Medical, Inc. K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC K152938DBB-06 Hemodialysis Delivery SystemNIKKISO CO., LTD. K143482xevonta dialyzerB. Braun Avitum AG K170790SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, Inc.

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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