FDA 510(k)

SANSIN 血液透析管路套件

K 號：K202796 · 2021-09-06

決定日期2021-09-06

產品代碼FJK

諮詢委員會GU

決定相當於

器材摘要

SANSIN Tubing Sets for Hemodialysis is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Sanxin Medtec Co., Ltd.. It received FDA 510(k) clearance on 2021-09-06 under 510(k) number K202796. 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 SANSIN Tubing Sets for Hemodialysis?

SANSIN Tubing Sets for Hemodialysis is a medical device that received FDA 510(k) clearance on 2021-09-06. The listed applicant is Jiangxi Sanxin Medtec Co., Ltd.. The 510(k) number is K202796.

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

SANSIN Tubing Sets for Hemodialysis received FDA 510(k) clearance on 2021-09-06, under 510(k) number K202796.

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

The FDA 510(k) record lists Jiangxi Sanxin Medtec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

其他以 Jiangxi Sanxin Medtec Co., Ltd. 為申請人之記錄

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K202719一次性醫療口罩

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。

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官方來源

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