FDA 510(k)

Moda-flx 靜脈透析系統™ 製劑 (102121-001)

K 號：K243607 · 2024-12-20

決定日期2024-12-20

產品代碼FJK

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

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。

K233798Moda-flx 血液透析系統及濾芯

相關器械（代碼：FJK）

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。

K252423NovaLine 血液透析管路組 (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd.K251341VITAL 血液透析管路套件Vital Healthcare Sdn. Bhd.K251442天一體外血液管路組合套件 (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.K213992CombiSet 靜脈透析血液管路組Fresenius Medical Care Renal Therapies Group, LLC K210782Tablo 壳蓋Outset Medical, Inc.K202796SANSIN 血液透析管路套件Jiangxi Sanxin Medtec Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。