FDA 510(k)

ST-Z5

K 號：K201878 · 2021-03-25

決定日期2021-03-25

產品代碼KCT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

ST-Z5 is the device name listed in this FDA 510(k) record. The listed applicant is Z-Systems AG. It received FDA 510(k) clearance on 2021-03-25 under 510(k) number K201878. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ST-Z5?

ST-Z5 is a medical device that received FDA 510(k) clearance on 2021-03-25. The listed applicant is Z-Systems AG. The 510(k) number is K201878.

When did ST-Z5 receive FDA 510(k) clearance?

ST-Z5 received FDA 510(k) clearance on 2021-03-25, under 510(k) number K201878.

Who is the listed applicant for ST-Z5?

The FDA 510(k) record lists Z-Systems AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ST-Z5?

The FDA product code for ST-Z5 is KCT.

其他以 Z-Systems AG 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。

K201712Z5-TL K200386Z5-BL K190243Z5-BL

相關器械（代碼：KCT）

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。

K253988LiteSet 盤子Nobel Biocare AB K261935外科及義肢托盤Dentsply Sirona, Inc.K253187SteriBest® 過濾消毒托盤系統Mastel Surgical K252854SteriTite容器系統搭配MediTray產品Case Medical, Inc.K260726斯特羅曼® ProClean™ 裝籠 (041.800 ; 041.801)Institut Straumann AG K253791PUREVUE™ 快速連接針筒系統托盤；PUREVUE™ 快速連接針筒系統蓋DePuy Mitek, Inc.

官方來源

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