FDA 510(k)

SC+ 血液透析机，SC+ 透析液胶囊，SC+ 血管套管套装

K号: K210661 · 2021-08-12

决定日期2021-08-12

产品代码KDI

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决定实质等同

器械摘要

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset 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 2021-08-12 under 510(k) number K210661. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is Quanta Dialysis Technologies, Ltd.. The 510(k) number is K210661.

When did SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset receive FDA 510(k) clearance?

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

Who is the listed applicant for SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset?

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

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

列明Quanta Dialysis Technologies, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242269SC+ 血液透析设备 (SC-14269)；透析液胶囊 (SC-14656)；血管套管套装 (SC-14651)K222067SC+ 血液透析设备，SC+ 透析液胶囊，SC+ 血管套管套装 K193670SC+ 血液透析机，SC+ 透析液胶囊，SC+ 血管套管套装

相关器械（代码：KDI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261267Careflux H60；Careflux H70；Careflux V500Fresenius Medical Care Renal Therapies Group, LLC K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC K260533ELISIO™-HNipro Medical Corporation K252459multiFlux 130（F00013123）；multiFlux 160（F00013124）Fresenius Medical Care Renal Therapies Group, LLC K253412Tablo血液透析系统（PN-0008000，PN-0006000U）Outset Medical, Inc.K253518FX CorAL 40；FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

官方来源

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