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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 the device name listed in this FDA 510(k) record. The listed applicant is Quanta Dialysis Technologies, Ltd.. It received FDA 510(k) clearance on 2020-12-23 under 510(k) 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. The listed applicant is Quanta Dialysis Technologies, Ltd.. The 510(k) number is K193670.

When did SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set receive FDA 510(k) clearance?

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

Who is the listed applicant for SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set?

The FDA 510(k) record lists Quanta Dialysis Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Quanta Dialysis Technologies, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)K222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube SetK210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset

Related Devices (Code: KDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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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