FDA 510(k)

Moda-flx血液透析系统™灌流器（102121-001）

K号: K243607 · 2024-12-20

决定日期2024-12-20

产品代码FJK

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决定实质等同

器械摘要

Moda-flx Hemodialysis System™ Cartridge (102121-001 ) is the device name listed in this FDA 510(k) record. The listed applicant is Diality, Inc.. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K243607. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Moda-flx Hemodialysis System™ Cartridge (102121-001 )?

Moda-flx Hemodialysis System™ Cartridge (102121-001 ) is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Diality, Inc.. The 510(k) number is K243607.

When did Moda-flx Hemodialysis System™ Cartridge (102121-001 ) receive FDA 510(k) clearance?

Moda-flx Hemodialysis System™ Cartridge (102121-001 ) received FDA 510(k) clearance on 2024-12-20, under 510(k) number K243607.

Who is the listed applicant for Moda-flx Hemodialysis System™ Cartridge (102121-001 )?

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™ Cartridge (102121-001 )?

The FDA product code for Moda-flx Hemodialysis System™ Cartridge (102121-001 ) is FJK.

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。

K233798Moda-flx血液透析系统及灌流器

官方来源

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