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FDA 510(k)

Moda-flx Hemodialysis System and Cartridge

K-Number: K233798 · 2024-08-02

ApplicantDiality, Inc.
Decision Date2024-08-02
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Moda-flx Hemodialysis System and Cartridge is a medical device manufactured by Diality, Inc.. It received FDA 510(k) clearance on 2024-08-02 under approval number K233798. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Diality, Inc.. The 510(k) number is K233798.

When was Moda-flx Hemodialysis System and Cartridge approved by the FDA?

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

What company makes Moda-flx Hemodialysis System and Cartridge?

Moda-flx Hemodialysis System and Cartridge is manufactured by Diality, Inc..

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.

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Other Devices by Diality, Inc.

K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )

Related Devices (Code: KDI)

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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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