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FDA 510(k)

Moda-flx Hemodialysis System™ Cartridge (102121-001 )

K-Number: K243607 · 2024-12-20

ApplicantDiality, Inc.
Decision Date2024-12-20
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Diality, Inc.. The 510(k) number is K243607.

When was Moda-flx Hemodialysis System™ Cartridge (102121-001 ) approved by the FDA?

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

What company makes Moda-flx Hemodialysis System™ Cartridge (102121-001 )?

Moda-flx Hemodialysis System™ Cartridge (102121-001 ) is manufactured by Diality, Inc..

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.

Related Clinical Trials

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Other Devices by Diality, Inc.

K233798Moda-flx Hemodialysis System and Cartridge

Related Devices (Code: FJK)

K150304Oxyless Blood Tubing SetOxyless, Ltd. K161582DORA Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. K171952Dimesol Tubing Sets for HemodialysisDimesol, Inc. K210782Tablo CartridgeOutset Medical, Inc. K202796SANSIN Tubing Sets for HemodialysisJiangxi Sanxin Medtec Co., Ltd. K201866NovaLine Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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