FDA 510(k)

RAPIDO HOLLOW-FIBRE DIALYZERS

K号: K160558 · 2016-11-18

决定日期2016-11-18

产品代码KDI

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决定实质等同

器械摘要

RAPIDO HOLLOW-FIBRE DIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Bellco Srl. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K160558. 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 RAPIDO HOLLOW-FIBRE DIALYZERS?

RAPIDO HOLLOW-FIBRE DIALYZERS is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Bellco Srl. The 510(k) number is K160558.

When did RAPIDO HOLLOW-FIBRE DIALYZERS receive FDA 510(k) clearance?

RAPIDO HOLLOW-FIBRE DIALYZERS received FDA 510(k) clearance on 2016-11-18, under 510(k) number K160558.

Who is the listed applicant for RAPIDO HOLLOW-FIBRE DIALYZERS?

The FDA 510(k) record lists Bellco Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPIDO HOLLOW-FIBRE DIALYZERS?

The FDA product code for RAPIDO HOLLOW-FIBRE DIALYZERS is KDI.

列明Bellco Srl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。

K231406ClearumTM HS K193542Clearum HS 系列，Clearum HS 型号：HS 13, HS 15, HS 17, HS 20, HS 22

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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