FDA 510(k)

Surdial DX血液透析系统

K号: K182940 · 2019-07-19

决定日期2019-07-19

产品代码KDI

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决定实质等同

器械摘要

Surdial DX Hemodialysis System is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2019-07-19 under 510(k) number K182940. 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 Surdial DX Hemodialysis System?

Surdial DX Hemodialysis System is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is Nipro Medical Corporation. The 510(k) number is K182940.

When did Surdial DX Hemodialysis System receive FDA 510(k) clearance?

Surdial DX Hemodialysis System received FDA 510(k) clearance on 2019-07-19, under 510(k) number K182940.

Who is the listed applicant for Surdial DX Hemodialysis System?

FDA 510(k)记录中列出了Nipro Medical Corporation为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Surdial DX Hemodialysis System?

The FDA product code for Surdial DX Hemodialysis System is KDI.

列明Nipro Medical Corporation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。

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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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