Optiflux Enexa F500 肾透析器
K号: K192928 · 2020-07-09
广告
决定日期2020-07-09
产品代码KDI
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
Optiflux Enexa F500 Dialyzer is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Reanal Therapies Group, LLC. It received FDA 510(k) clearance on 2020-07-09 under 510(k) number K192928. 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 Optiflux Enexa F500 Dialyzer?
Optiflux Enexa F500 Dialyzer is a medical device that received FDA 510(k) clearance on 2020-07-09. The listed applicant is Fresenius Medical Care Reanal Therapies Group, LLC. The 510(k) number is K192928.
When did Optiflux Enexa F500 Dialyzer receive FDA 510(k) clearance?
Optiflux Enexa F500 Dialyzer received FDA 510(k) clearance on 2020-07-09, under 510(k) number K192928.
Who is the listed applicant for Optiflux Enexa F500 Dialyzer?
The FDA 510(k) record lists Fresenius Medical Care Reanal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Optiflux Enexa F500 Dialyzer?
The FDA product code for Optiflux Enexa F500 Dialyzer is KDI.
相关临床试验
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。
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, 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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告