FDA 510(k)

DBB-06 血液透析输送系统

K号: K152938 · 2016-03-18

决定日期2016-03-18

产品代码KDI

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决定实质等同

器械摘要

DBB-06 Hemodialysis Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is NIKKISO CO., LTD.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K152938. 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 DBB-06 Hemodialysis Delivery System?

DBB-06 Hemodialysis Delivery System is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is NIKKISO CO., LTD.. The 510(k) number is K152938.

When did DBB-06 Hemodialysis Delivery System receive FDA 510(k) clearance?

DBB-06 Hemodialysis Delivery System received FDA 510(k) clearance on 2016-03-18, under 510(k) number K152938.

Who is the listed applicant for DBB-06 Hemodialysis Delivery System?

The FDA 510(k) record lists NIKKISO CO., LTD. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DBB-06 Hemodialysis Delivery System?

The FDA product code for DBB-06 Hemodialysis Delivery System is KDI.

列明NIKKISO CO., 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。

K242155DBB-06 PRO 血液透析输送系统 (DBB-06 PRO)K242479血液透析用管路 AL 系列产品 (Archloop) 血液透析用管路 C18 系列产品 AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU K242176血液透析用管路 AL 系列产品 (Archloop) 血液透析用管路 C18 系列产品 (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U))K231589血液透析管路AV06C-E K230514血液透析管路AL系列（Archloop），血液透析管路C18系列

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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