FDA 510(k)

Dimesol 血液透析管路套件

K 號：K171952 · 2018-03-30

決定日期2018-03-30

產品代碼FJK

諮詢委員會GU

決定相當於

器材摘要

Dimesol Tubing Sets for Hemodialysis is the device name listed in this FDA 510(k) record. The listed applicant is Dimesol, Inc.. It received FDA 510(k) clearance on 2018-03-30 under 510(k) number K171952. 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 Dimesol Tubing Sets for Hemodialysis?

Dimesol Tubing Sets for Hemodialysis is a medical device that received FDA 510(k) clearance on 2018-03-30. The listed applicant is Dimesol, Inc.. The 510(k) number is K171952.

When did Dimesol Tubing Sets for Hemodialysis receive FDA 510(k) clearance?

Dimesol Tubing Sets for Hemodialysis received FDA 510(k) clearance on 2018-03-30, under 510(k) number K171952.

Who is the listed applicant for Dimesol Tubing Sets for Hemodialysis?

The FDA 510(k) record lists Dimesol, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dimesol Tubing Sets for Hemodialysis?

The FDA product code for Dimesol Tubing Sets for Hemodialysis is FJK.

其他以 Dimesol, 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。

K171505Dimesol 一次性動靜脈造口針組（非安全系列）及Dimesol 一次性動靜脈造口針組（安全系列）

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.K243607Moda-flx 靜脈透析系統™ 製劑 (102121-001)Diality, Inc.K213992CombiSet 靜脈透析血液管路組Fresenius Medical Care Renal Therapies Group, LLC K210782Tablo 壳蓋Outset Medical, Inc.

官方來源

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