FDA 510(k)

Moda-flx 血液透析系統及濾芯

K 號：K233798 · 2024-08-02

決定日期2024-08-02

產品代碼KDI

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Diality, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K243607Moda-flx 靜脈透析系統™ 製劑 (102121-001)

相關器械（代碼：KDI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261267Careflux H60；Careflux H70；Careflux V500Fresenius Medical Care Renal Therapies Group, LLC K252377NxStage System One 配 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血液透析系統（PN-0008000，PN-0006000U）Outset Medical, Inc.K253518FX珊瑚40；FX珊瑚50Fresenius Medical Care Renal Therapies Group, LLC

官方來源

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