FDA 510(k)

Moda-flx血液透析系统及灌流器

K号: K233798 · 2024-08-02

决定日期2024-08-02

产品代码KDI

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决定实质等同

器械摘要

Moda-flx Hemodialysis System and Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Diality, Inc.. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K233798. 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 Moda-flx Hemodialysis System and Cartridge?

Moda-flx Hemodialysis System and Cartridge is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Diality, Inc.. The 510(k) number is K233798.

When did Moda-flx Hemodialysis System and Cartridge receive FDA 510(k) clearance?

Moda-flx Hemodialysis System and Cartridge received FDA 510(k) clearance on 2024-08-02, under 510(k) number K233798.

Who is the listed applicant for Moda-flx Hemodialysis System and Cartridge?

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

What is the FDA product code for Moda-flx Hemodialysis System and Cartridge?

The FDA product code for Moda-flx Hemodialysis System and Cartridge is KDI.

列明Diality, Inc.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。

K243607Moda-flx血液透析系统™灌流器（102121-001）

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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