FDA 510(k)

矽膠單次使用福萊氏導尿管

K 號：K172807 · 2018-06-04

申請人Changzhou Rongxin Medicine Minimal Invasion Technology

決定日期2018-06-04

產品代碼EZL

諮詢委員會GU

決定相當於

器材摘要

Silicone Foley Catheter for single use is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Rongxin Medicine Minimal Invasion Technology. It received FDA 510(k) clearance on 2018-06-04 under 510(k) number K172807. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Silicone Foley Catheter for single use?

Silicone Foley Catheter for single use is a medical device that received FDA 510(k) clearance on 2018-06-04. The listed applicant is Changzhou Rongxin Medicine Minimal Invasion Technology. The 510(k) number is K172807.

When did Silicone Foley Catheter for single use receive FDA 510(k) clearance?

Silicone Foley Catheter for single use received FDA 510(k) clearance on 2018-06-04, under 510(k) number K172807.

Who is the listed applicant for Silicone Foley Catheter for single use?

The FDA 510(k) record lists Changzhou Rongxin Medicine Minimal Invasion Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silicone Foley Catheter for single use?

The FDA product code for Silicone Foley Catheter for single use is EZL.

相關器械（代碼：EZL）

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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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：EZL）

官方來源